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This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.
This single-arm trial will enroll patients with biopsy confirmed or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging. A total of up to 40 patients will be enrolled in this trial. The sponsor reserves the right to perform an interim analysis following early enrollment (i.e., n ≤ 10 subjects) to determine the feasibility and benefit of pegsitacianine as an adjunct to standard of care surgical resection of lung malignancies.
The surgeon will begin by attempting to perform their SOC tumor resection. If the tumor is unable to be located under standard white light conditions, an appropriate FDA-cleared near-infrared imaging device may be used to aid in the location of the primary tumor. Localization of the primary tumor, when unable to be located using white light imaging, in conjunction with pathology confirmed presence of disease will be considered a clinically significant event. Following any standard of care procedures conducted under white light only, the near infrared camera will be used to evaluate areas of residual fluorescence that may be resected if suscpicious for metastatic spread or residual margins. The fluorescence status of each specimen will then be correlated to the final pathology for each, and performance metrics of pegsitacianine will be tabulated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescence imaging with pegsitacianine | Experimental | Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegsitacianine | Drug | An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE) | Discovery of a clinically significant event at the level of the patient. May include detection of primary tumors, discovery of occult disease, or tumor negative SOC biopsies. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen | # of true positive specimens divided by the (#of true positive specimens + # of false negative specimens) | 7 days |
| Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Singhal, MD | Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| The University of Texas MD Anderson Cancer Center |
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| Label | URL |
|---|---|
| A Phase 2 Multicenter Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer with a pH-Activatable Nanoprobe | View source |
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Patients scheduled for surgical excision of pulmonary lesions were eligible for enrollment. The study was conducted at two large cancer surgical centers from from April 13, 2022 through August 31, 2022. Four patients withdrew consent prior to dosing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluorescence Imaging With Pegsitacianine | Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery. pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluorescence Imaging With Pegsitacianine | Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery. pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Proportion of Patients Experiencing at Least One Clinically Significant Event (CSE) | Discovery of a clinically significant event at the level of the patient. May include detection of primary tumors, discovery of occult disease, or tumor negative SOC biopsies. | Patients that received at least 75% of planned dose, had at least 1 image collected, and had disease present | Posted | Count of Participants | Participants | 1 day |
|
Adverse events were collected from time of infusion (24 hours prior to surgery) through 28 days post surgery.
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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 | Fluorescence Imaging With Pegsitacianine | Pegsitacianine 1 mg/ml infused 24-72 hours prior to surgery. pegsitacianine: An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | non-drug related complication due to surgical procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Operations | OncoNano Medicine, Inc | (682) 285-1411 | trials@onconanomed.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 25, 2022 | Nov 6, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2022 | Nov 6, 2024 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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An interventional, open-label, single arm trial where each patient is his/her own intrapatient control. All patients will receive a single dose of pegsitacianine administered intravenously prior to standard of care (SOC) surgery.
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| Tumor resection surgery | Procedure | Standard of care surgical removal of cancerous lung lesion |
|
# of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens) |
| 7 days |
| Negative Predictive Value of Pegsitacianine | # of True negative specimens divided by the (# of true negative specimens + # of false negative specimens) | 7 days |
| Positive Predictive Value of Pegsitacianine | # of true positive specimens divided by the (# of true positive + # of false positive specimens) | 7 days |
| Houston |
| Texas |
| 77030 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Sensitivity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen | # of true positive specimens divided by the (#of true positive specimens + # of false negative specimens) | non-lymph node tissue specimens from lung resection | Posted | Number | 95% Confidence Interval | ratio | 7 days | tissue specimens | tissue specimens |
|
|
|
| Secondary | Specificity of Pegsitacianine at Detecting Presence of Tumor Within the Tissue Specimen | # of True Negative Specimens divided by the (# of True Negative Specimens + # of False Positive Specimens) | non-lymph node lung tissue specimens | Posted | Number | 95% Confidence Interval | ratio | 7 days | tissue specimens | tissue specimens |
|
|
|
| Secondary | Negative Predictive Value of Pegsitacianine | # of True negative specimens divided by the (# of true negative specimens + # of false negative specimens) | non-lymph node tissue specimens | Posted | Number | 95% Confidence Interval | ratio | 7 days | tissue specimens | tissue specimens |
|
|
|
| Secondary | Positive Predictive Value of Pegsitacianine | # of true positive specimens divided by the (# of true positive + # of false positive specimens) | non-lymph node lung tissue specimens | Posted | Number | 95% Confidence Interval | ratio | 7 days | tissue specimens | tissue specimens |
|
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| 19 |
| 20 |
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| Subcutaneoius Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Infusion Related Reactions | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pulmonary Air Leakage | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |