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This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures as confirmed by Technitium99m (Tc99m) and Gamma Probe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC2000/SPY-PHI | Experimental | Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC2000 and SPY-PHI | Combination Product | Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe | From Technetium-99 (Tc-99m) injection to the completion of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe | From Technetium-99 (Tc-99m) injection to the completion of surgery | |
| Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI |
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Inclusion Criteria:
Be 18 years of age or older
Subjects with American Cancer Society Clinical Stage 0 Ductal Carcinoma in Situ (DCIS) (Stage 0, Tis, N0, M0), IA (T1*, N0, M0), IB ((T0, N1mi, M0) or T1*, N1mi, M0)) or Stage IIA (T0, N1**M0, or T1, N1**, M0 or T2, N0, M0)1 breast cancer undergoing surgery to remove tumor draining LNs.
Where:
Subjects with clinically negative nodal status (N0) with or without neoadjuvant chemotherapy
Subjects with negative metastatic involvement (M0)
Subjects of child-bearing potential must not be pregnant or lactating and must have a negative pregnancy test at Baseline
Have signed an approved informed consent form for the study
Be willing to comply with the protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Weintritt, MD, FACS | National Breast Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Center for Cancer Care | Scottsdale | Arizona | 85258 | United States | ||
| MedStar Georgetown University Hospital |
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Subjects assessed for eligibility (n=153)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | IC2000/SPY-PHI | Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised. IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Aug 13, 2020 |
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Single arm, open label, within patient study
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|
| Tc-99m radioactive colloid and Gamma Probe | Combination Product | Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer |
|
| From Technetium-99 (Tc-99m) injection to the completion of surgery |
| To Assess the Safety of Intradermal Injection of IC2000 | Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0 | From Technetium-99 (Tc-99m) injection to the completion of surgery |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | United States |
| Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| Inova Health System | Alexandria | Virginia | 22306 | United States |
| Fraser Health Authority | Port Moody | British Columbia | V3H 3W9 | Canada |
| CHU de Québec-Université Laval (Hôpital du Saint-Sacrement) | Québec | Quebec | G1R 2J6 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Total enrollment (N=152)
*PP and mITT population (N=148)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IC2000/SPY-PHI | Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised. IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | *PP/ mITT population (N=148) | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | *PP/ mITT population (N=148) | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | *PP/ mITT population (N=148) | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | *Please note, the region of enrollment total reflects total subjects enrolled (N=152) | Number | participants |
| |||||||||||||||
| Smoker, n (%) | *PP/ mITT population (N=148) | Count of Participants | Participants |
| |||||||||||||||
| Alcohol consumption, n (%) | *PP/ mITT population (N=148) | Count of Participants | Participants |
| |||||||||||||||
| Comorbid conditions of interest, n (%) | *PP/ mITT population (N=148) | 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 | Proportion of Lymph Nodes Identified by IC2000/SPY-PHI Compared to the Proportion of Lymph Nodes Identified by Tc99m/Gamma Probe | PP and mITT populations | Posted | Count of Units | Lymph Nodes | From Technetium-99 (Tc-99m) injection to the completion of surgery | Lymph Nodes | Lymph Nodes |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With at Least One Lymph Node Identified by IC2000/SPY-PHI, and the Proportion of Subjects With at Least One Lymph Node Identified by Tc99m/Gamma Probe | PP and mITT population *The PP and mITT populations were identical | Posted | Count of Participants | Participants | From Technetium-99 (Tc-99m) injection to the completion of surgery |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Lymph Nodes Identified by IC2000/SPY-PHI by Following a Fluorescent Lymphatic Vessel, and the Proportion of Identified Lymph Nodes With no Lymphatic Vessels Visible by IC2000/SPY-PHI | Total number of histology confirmed clinical lymph nodes (specimens) identified and excised by IC2000 and SPY. *The PP and mITT populations were identical | Posted | Count of Units | Lymph Nodes | From Technetium-99 (Tc-99m) injection to the completion of surgery | Lymph Nodes | Lymph Nodes |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | To Assess the Safety of Intradermal Injection of IC2000 | Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0 | Safety cohort (N=151) | Posted | Count of Participants | Participants | From Technetium-99 (Tc-99m) injection to the completion of surgery |
|
Collected over the treatment duration period (Day 0) and followed through to Day 30
The All-Cause Mortality, Serious Adverse Event, and Adverse events are listed for the safety population and some subjects reported more than one AE or SAE.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IC2000/SPY-PHI | Per standard of care, each subject will receive an injection of Tc-99m radioactive colloid. Then the periareolar area of the breast(s) identified with breast cancer will be injected (intradermal) twice with 0.05 ml of a 2.5 mg/ml solution of IC2000. Following the injection lymph node mapping will occur based on intraoperative fluorescence visualization using IC2000 and SPY-PHI. Lymph nodes will be excised following identification with IC2000 and SPY-PHI. The Gamma Probe will then be used with Tc-99m for confirmation of the excised lymph nodes as well as in the area of LN excision to ensure all LNs have been identified and excised. IC2000 and SPY-PHI: Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer Tc-99m radioactive colloid and Gamma Probe: Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer | 0 | 151 | 4 | 151 | 27 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Oxygen saturation decreased | Investigations | Non-systematic Assessment | A subject may have reported more than one Adverse Events. *Five serious adverse events, of which one ("Apneic Episode Desaturation") was split into two different terms, 'Oxygen Saturation Decreased' and 'Apnea', therefore resulting in six SAEs. |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. *Five serious adverse events, of which one ("Apneic Episode Desaturation") was split into two different terms, 'Oxygen Saturation Decreased' and 'Apnea', therefore resulting in six SAEs. |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Hypertension | Vascular disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Angina Pectoris | Cardiac disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Atrial Fibrillation | Cardiac disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Goitre | Endocrine disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Fatigue | General disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Injection site discoloration | General disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Clostridium difficile colitis | Infections and infestations | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Wound Infection | Infections and infestations | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Procedural Nausea | Injury, poisoning and procedural complications | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Seroma | Injury, poisoning and procedural complications | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Skin Flap Necrosis | Injury, poisoning and procedural complications | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Wound Secretion | Injury, poisoning and procedural complications | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Oxygen Saturation Decreased | Investigations | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Chest Wall Hematoma | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Device Occlusion | Product Issues | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Apnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Ischemic Skin Ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Skin Discoloration | Skin and subcutaneous tissue disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Skin Necrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Deep Vein Thrombosis | Vascular disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Flushing | Vascular disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
| |
| Hypertension | Vascular disorders | Non-systematic Assessment | A subject may have reported more than one Adverse Events. |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colleen Roden, Director of Clinical Sciences and Operations | Novadaq Technologies ULC, now a part of Stryker | 931-267-2041 | colleen.roden@stryker.com |
| Jul 27, 2023 |
| Prot_SAP_000.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
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| Male |
|
| Black or African |
|
| Asian |
|
| Hispanic |
|
| Other |
|
| United States |
|
|
| Past |
|
| Never |
|
| No |
|
| Cardiac Disease |
|
| COPD |
|
| Diabetes |
|
| Renal Failure |
|
| Liver Disease |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|
| Participants |
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