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Study terminated due to closure of Sponsor business
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Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the cancer while conserving as much of the surrounding healthy tissue as possible. Current methods do not allow surgeons to determine the completeness of surgical resection in real-time. This often results in the need for a second surgical procedure, or in some cases more than two surgical procedures in order to have confidence that all cancer has been removed.
This Phase 3 study will evaluate the safety and efficacy of the fluorescent imaging agent PD G 506 A for the real-time visualization of cancer during standard of care breast conserving surgery. PD G 506 A is an investigational drug which is converted in the body into a fluorescent molecule that accumulates in cancer cells. Patients receiving PD G 506 A will undergo standard of care breast conserving surgery followed by fluorescence imaging and removal of any potentially cancerous tissue left behind in the surgical cavity.
Re-operations due to positive margins following breast conserving surgery (BCS) increase poor cosmesis, complications, discomfort, stress, adjuvant delay, medical costs and risk of local recurrence. Reducing positive margin rates can be achieved through optimizing surgical procedures. This study evaluates a new method for surgeons to visualize carcinoma in real-time, both in the surgical cavity and on the margins of excised specimen(s) during the index BCS procedure.
The active ingredient of PD G 506A is aminolevulinic acid hydrochloride (ALA HCl). ALA HCl is a prodrug that is metabolized intracellularly to form the fluorescent molecule protoporphyrin IX (PpIX). The exogenous application of ALA HCl leads to a highly selective accumulation of PpIX in malignant tissues.
This Phase 3, 2-part, single-blind [pathologist(s)-blinded] randomized placebo-controlled trial study is designed to evaluate the efficacy and safety of PD G 506 A to aid in the visualization of carcinoma during BCS. The Eagle V1.2 Imaging System will be used in this trial to visualize PpIX fluorescence.
Part A is an open-label training phase of the study to optimize workflow and Part B of the study is randomized and single-blind and will serve as the pivotal portion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Arm | Placebo Comparator | Patients in this arm will receive the placebo orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging will be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence-guided resection will not be performed in patients in this arm. |
|
| PD G 506 A + Fluorescence-Guided Resection Arm | Experimental | Patients in this arm will receive PD G 506 A orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging will be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence imaging performed after SoC BCS is complete will guide the resection of additional tissue. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aminolevulinic Acid Hydrochloride | Drug | PD G 506 A for oral solution (aminolevulinic acid [ALA] hydrochloride [HCl] granules for oral solution) is administered as a single dose (20 mg/kg body weight) approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Margin Conversion Rate | Percentage of patients with negative-margins following fluorescence-guided resection (FGR) among patients all patients imaged | 2 weeks |
| Diagnostic Performance (Specificity) | Patient-level specificity to identify residual carcinoma | 2 weeks |
| Diagnostic Performance (Sensitivity) | Patient-level sensitivity to identify residual carcinoma | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Orientation-level Diagnostic Performance | Orientation-level diagnostic performance of PD G 506 A-induced fluorescence to determine the presence or absence of cancer in the surgical cavity as compared to margin histopathology. | 2 weeks |
| Positive Margin Conversion Rate Among All Patients |
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Inclusion Criteria:
Exclusion Criteria:
Currently on (neo)adjuvant therapy to treat another cancer
Receiving or intended to receive neoadjuvant therapy to treat the primary breast cancer (including chemotherapy, endocrine therapy and radiotherapy)
Stage 4 cancer, inclusive of metastatic disease
Non-invasive diseases of the breast (includes lobular carcinoma in situ, phyllodes and Paget's disease of the breast)
Patients who have had the following procedures performed on the involved breast:
Patients for whom intraoperative frozen section analysis is planned
Patients who have not recovered from adverse events due an investigational pharmaceutical or diagnostic agents administered more than 30 days prior to their scheduled surgical procedure
History of hypersensitivity to ALA HCl or porphyrins
Known or documented personal or family history of porphyria
Patient has a recording of any parameter as defined below:
Patient has serum creatinine >1.5 times institutional upper limit of normal, OR calculated creatinine clearance > 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal.
Uncontrolled concurrent illness, that in the opinion of the Investigator would prevent the patient from participation in the study, including but not limited to:
Patients who have the following collagen vascular diseases:
Use of an investigational drug within 30 days of their scheduled surgical procedure
Simultaneous use of other potentially phototoxic substances (such as St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period.
Social or medical situations including uncontrolled psychiatric illnesses that would in the opinion of the Investigator limit compliance with study requirements (e.g. ability to travel for follow-up)
Patients who are pregnant or become pregnant (it is unknown if ALA HCl is teratogenic or has abortifacient effects)
Patients who are breast feeding (there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ALA HCl, breastfeeding should be discontinued if the mother is treated with ALA HCl)
Inability to consent
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| Name | Affiliation | Role |
|---|---|---|
| Ralph DaCosta, PhD | SBI ALApharma Canada | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stamford Hospital | Stamford | Connecticut | 06902 | United States | ||
| BayCare Morton Plant Hospital |
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Fifty-seven (57) patients were enrolled for baseline characteristics as indicated in eligibility criteria prior to assignment in Part A of the study. Four (4) enrolled patients were excluded after enrollment due not meeting eligibility requirements. Three (3) patients who were enrolled were not completed due to a physician decision (1 patient) or a study pause (2 patients). The Part B (randomized and placebo controlled) was never initiated. The trial was terminated beforehand.
Participants were recruited between 04/27/2021 and 08/30//2025. Patients were recruited by their surgeon at surgical clinic visits. Participants were recruited at each of the 7 study sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | PD G 506 A + Fluorescence-Guided Resection Arm | Patients in this arm will receive PD G 506 A orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging will be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence imaging performed after SoC BCS is complete will guide the resection of additional tissue. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2024 |
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Part A of the study is open-label. All patients in Part A will receive the investigational drug and will undergo standard of care breast conserving surgery (BCS) followed by fluorescence-guided resection. Part B of the study is randomized and placebo controlled; patients will be randomized to receive placebo + standard of care BCS alone or PD G 506 A + SoC BCS followed by fluorescence-guided resection.
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In Part B, the participant and pathologist will be blind to treatment arm allocation for the duration of the study. The surgeon will be blind to treatment arm allocation up until the time that standard of care resection is complete. The blind will be broken during the surgical procedure after the surgeon declares standard of care resection complete.
|
| Eagle V1.2 Imaging System | Device | Fluorescence imaging camera and associated accessories used to view and capture fluorescence and white light images and videos of the surgical cavity and excised tissue specimens during the surgical procedure. |
|
| Placebo | Drug | Oral placebo is administered as a single dose approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia. |
|
Percentage of patients with at least one histopathology-positive margin following SoC who then have ALL histopathology-negative margins following FGR, among all patients imaged. |
| 2 weeks |
| Patient-level Diagnostic Performance | Patient-level sensitivity, specificity, NPV, PPV of PD G 506 A-induced fluorescence to determine the presence or absence of residual cancer. | 2 weeks |
| Patient-level Diagnostic Performance of PD G 506 A to Detect Residual Cancer at the End of FGR With Modified Patient-level Definitions | Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of residual cancer in the surgical cavity at the end of FGR (using modified patient-level definitions). | 2 weeks |
| Patient-level Diagnostic Performance of PD G 506 A to Detect Cancer After SoC BCS | Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of cancer in the surgical cavity after SoC BCS. | 2 weeks |
| Patient-level Diagnostic Performance of PD G 506 A to Detect Cancer After SoC With Modified Patient-level Definitions | Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of cancer in the surgical cavity after SoC (using modified patient-level definitions). | 2 weeks |
| Patient-level False Negative Rate of at the End of FGR | Percentage of patients assessed as residual tumor negative at the end of FGR who had positive final margins on histopathology. | 2 weeks |
| Patient-level False Positive Rate | Percentage of patients in whom SOC final margins were carcinoma negative and all FL-driven shave specimens are carcinoma-negative. | 2 weeks |
| Patients With Carcinoma-negative Margins After SoC Found to Have Residual Tumor Following SoC That Was Identified With FL Imaging | Percentage of patients with histopathology-negative margins at the end of SoC who have at least one orientation that was both FL-positive and histopathology-positive among (1) patients with histopathology negative final margins after SOC and (2) all patients imaged. | 2 weeks |
| Patient-level True Negative Rate at the End of SoC | Percentage of patients with no fluorescence identified at the end of SoC in whom all final margins after SoC are histopathologically confirmed to be negative for carcinoma. | 2 weeks |
| Patient-level Diagnostic Performance to Identify in Vivo Residual Carcinoma After FGR | Patient-level in vivo diagnostic performance of PD G 506 A-induced fluorescence to determine the presence or absence of residual cancer in the surgical cavity at the end of FGR as compared to the final margin histopathology. | 2 weeks |
| Orientation Discordant Fluorescence Status | Percentage of orientations where in vivo and ex vivo fluorescence assessments are discordant. | 2 weeks |
| Patient-level Re-operation Rate | Percentage of patients receiving a 2nd surgery on the ipsilateral breast within 1 year of index BCS to remove suspected residual disease. | 1 year |
| Patient-level Early Re-operation Rate | Percentage of patients receiving an early 2nd surgery (planned or actual) on the ipsilateral breast related to positive final margins. | 3 - 6 months |
| Amount of Tissue Removed With FGR Beyond SoC | Weight (mg) of all tissue removed based on SoC and/of FGR. | 3 - 6 months |
| Patient Satisfaction With Breast | Patient satisfaction with the cosmetic outcome of breast conserving surgery performed based on SoC in combination with PD G 506 A and the Eagle V1.2 Imaging System. | 2 weeks, 3-, 6- and 12-months |
| Clearwater |
| Florida |
| 33756 |
| United States |
| University of Miami Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Orlando Health, Inc. | Orlando | Florida | 32806 | United States |
| BayCare St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Aurora St. Luke's Medical Centre | Milwaukee | Wisconsin | 53215 | United States |
| PD G 506 A + Fluorescence-Guided Resection Arm |
|
| COMPLETED | Participants were recruited exclusively for Part A. Participants completed the study in full accordance with the protocol, before data collection for the endpoints in Part B. |
|
| NOT COMPLETED |
|
|
The aim of Part A of the study is to provide training to the participating sites on the study procedures, and to determine the final number of subjects required for analysis of the endpoints in Part B of the study. The study was terminated early after the completion of Part A and before the start of Part B.
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| ID | Title | Description |
|---|---|---|
| BG000 | PD G 506 A + Fluorescence-Guided Resection (Part A) | Patients in this arm received PD G 506 A orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging was be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence image-guided resection was performed after SoC BCS was complete. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Diagnosis | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Margin Conversion Rate | Percentage of patients with negative-margins following fluorescence-guided resection (FGR) among patients all patients imaged | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
|
| |||||||||||||||||||
| Primary | Diagnostic Performance (Specificity) | Patient-level specificity to identify residual carcinoma | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
|
| |||||||||||||||||||
| Primary | Diagnostic Performance (Sensitivity) | Patient-level sensitivity to identify residual carcinoma | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
|
| |||||||||||||||||||
| Secondary | Orientation-level Diagnostic Performance | Orientation-level diagnostic performance of PD G 506 A-induced fluorescence to determine the presence or absence of cancer in the surgical cavity as compared to margin histopathology. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
| ||||||||||||||||||||
| Secondary | Positive Margin Conversion Rate Among All Patients | Percentage of patients with at least one histopathology-positive margin following SoC who then have ALL histopathology-negative margins following FGR, among all patients imaged. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
| ||||||||||||||||||||
| Secondary | Patient-level Diagnostic Performance | Patient-level sensitivity, specificity, NPV, PPV of PD G 506 A-induced fluorescence to determine the presence or absence of residual cancer. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
|
| |||||||||||||||||||
| Secondary | Patient-level Diagnostic Performance of PD G 506 A to Detect Residual Cancer at the End of FGR With Modified Patient-level Definitions | Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of residual cancer in the surgical cavity at the end of FGR (using modified patient-level definitions). | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
| ||||||||||||||||||||
| Secondary | Patient-level Diagnostic Performance of PD G 506 A to Detect Cancer After SoC BCS | Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of cancer in the surgical cavity after SoC BCS. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
| ||||||||||||||||||||
| Secondary | Patient-level Diagnostic Performance of PD G 506 A to Detect Cancer After SoC With Modified Patient-level Definitions | Patient-level sensitivity, specificity, PPV and NPV to determine the presence or absence of cancer in the surgical cavity after SoC (using modified patient-level definitions). | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
| ||||||||||||||||||||
| Secondary | Patient-level False Negative Rate of at the End of FGR | Percentage of patients assessed as residual tumor negative at the end of FGR who had positive final margins on histopathology. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
| ||||||||||||||||||||
| Secondary | Patient-level False Positive Rate | Percentage of patients in whom SOC final margins were carcinoma negative and all FL-driven shave specimens are carcinoma-negative. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
|
| |||||||||||||||||||
| Secondary | Patients With Carcinoma-negative Margins After SoC Found to Have Residual Tumor Following SoC That Was Identified With FL Imaging | Percentage of patients with histopathology-negative margins at the end of SoC who have at least one orientation that was both FL-positive and histopathology-positive among (1) patients with histopathology negative final margins after SOC and (2) all patients imaged. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
| ||||||||||||||||||||
| Secondary | Patient-level True Negative Rate at the End of SoC | Percentage of patients with no fluorescence identified at the end of SoC in whom all final margins after SoC are histopathologically confirmed to be negative for carcinoma. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
| ||||||||||||||||||||
| Secondary | Patient-level Diagnostic Performance to Identify in Vivo Residual Carcinoma After FGR | Patient-level in vivo diagnostic performance of PD G 506 A-induced fluorescence to determine the presence or absence of residual cancer in the surgical cavity at the end of FGR as compared to the final margin histopathology. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
| ||||||||||||||||||||
| Secondary | Orientation Discordant Fluorescence Status | Percentage of orientations where in vivo and ex vivo fluorescence assessments are discordant. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks |
|
| |||||||||||||||||||
| Secondary | Patient-level Re-operation Rate | Percentage of patients receiving a 2nd surgery on the ipsilateral breast within 1 year of index BCS to remove suspected residual disease. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 1 year |
|
| |||||||||||||||||||
| Secondary | Patient-level Early Re-operation Rate | Percentage of patients receiving an early 2nd surgery (planned or actual) on the ipsilateral breast related to positive final margins. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 3 - 6 months |
|
| |||||||||||||||||||
| Secondary | Amount of Tissue Removed With FGR Beyond SoC | Weight (mg) of all tissue removed based on SoC and/of FGR. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 3 - 6 months |
|
| |||||||||||||||||||
| Secondary | Patient Satisfaction With Breast | Patient satisfaction with the cosmetic outcome of breast conserving surgery performed based on SoC in combination with PD G 506 A and the Eagle V1.2 Imaging System. | The study was terminated early after the completion of Part A, before data collection for the analysis of the endpoints in Part B had begun, as per the protocol. The only objectives of Part A were to conduct training for the participating trial sites and to optimize the study workflow for Part B, so this endpoint will not be analysed. | Posted | 2 weeks, 3-, 6- and 12-months |
|
All adverse events were followed from the time of consent to through to the Week 2 visit (~14 days after surgery). If a serious or non-serious adverse event (AE) was recorded at the Week 2 visit, the participant was assessed for an additional 7 days for non-serious adverse events or for at least an additional 30 calendar days for serious adverse events following the Week 2 visit. Any serious adverse events were followed until resolution or stabilization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PD G 506 A + Fluorescence-Guided Resection Arm (Part A) | Patients in this arm will receive PD G 506 A orally approximately 3 hrs prior to anesthesia followed by standard of care BCS. Fluorescence imaging will be performed on tissue specimens resected prior to completion of standard of care resection. Fluorescence imaging performed after SoC BCS is complete will guide the resection of additional tissue. Aminolevulinic Acid Hydrochloride: PD G 506 A for oral solution (aminolevulinic acid [ALA] hydrochloride [HCl] granules for oral solution) is administered as a single dose (20 mg/kg body weight) approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia. Eagle V1.2 Imaging System: Fluorescence imaging camera and associated accessories used to view and capture fluorescence and white light images and videos of the surgical cavity and excised tissue specimens during the surgical procedure. | 0 | 50 | 1 | 50 | 16 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | CTCAE (5.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment | Post-operative pain in affected breast |
|
| Nausea | Gastrointestinal disorders | CTCAE (5.0) | Non-systematic Assessment |
| |
| Skin burning sensation | Skin and subcutaneous tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
|
Study was terminated early prior to meeting expected enrolment for Part A. No formal data analysis was performed.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Clinical Development & Regulatory Affairs | photonamic GmbH & Co. KG | +49 (0)4101 78539 09 | info@photonamic.de |
| Jun 2, 2025 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Other (± in situ carcinoma) |
|
| Not Reported |
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