VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02294565|
Recruitment Status : Unknown
Verified July 2015 by Vestan, Inc..
Recruitment status was: Recruiting
First Posted : November 19, 2014
Last Update Posted : July 27, 2015
The purpose of this Phase 1 portion of this clinical research study is to find out what dose of dilute fluorescein is needed for a surgeon to best see important lymph nodes that need to be removed during surgery (a standard of care surgery referred to as a Sentinel Lymph Node Biopsy procedure) in patients diagnosed with breast cancer.
The purpose of the Phase 2 portion of this clinical research study is to find out if giving dilute fluorescein sodium in combination with a radiotracer (a drug that is radioactive) can help surgeons localize the lymph nodes that need to be removed in patients diagnosed by breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: VST-1001 Drug: 99mTc-labeled sulfur colloid||Phase 1 Phase 2|
The study is a single center prospective, non randomized, single arm, open label, single dose VST-1001 study for lymphatic mapping and localization of lymph nodes draining a primary tumor site in patients with clinically node negative breast cancer.
This study evaluates the combined modality technique of investigational VST-1001 with companion medical devices (replacing the blue dye) and 99mTc-labeled sulfur colloid for concordance in lymphatic mapping and localization of lymph nodes in patients who are undergoing a sentinel lymph node biopsy (SLNB) surgical procedure.
This purpose of the Phase I study is to determine a safe and effective recommended dose of VST-1001 for intraoperative lymphatic mapping and localization of lymph nodes draining a breast tumor. The purpose of the Phase II study is to further evaluate the Phase I study recommended dose of VST-1001 and to evaluate its ability to provide intraoperative visualization of the lymphatic system and lymph nodes draining the primary tumor in patients diagnosed with breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||147 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of VST-1001 (Dilute Fluorescein) for Lymphatic Mapping and Localization of Lymph Nodes Draining a Primary Tumor Site in Patients With Clinically Node Negative Breast Cancer|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||May 2016|
VST-1001 & 99mTc-labeled sulfur colloid
VST-1001 (with medical devices) and 99mTc-labeled sulfur colloid are used together during a SLNB procedure in a single subject. Both drugs are evaluated for lymphatic mapping and localization of lymph nodes. The current standard of care for lymphatic mapping and lymph node localization during a SLNB procedure is a combined-modality technique that employs both a radiotracer (99mTc-labeled sulfur colloid is the radiotracer used in this study) and a vital blue dye (a patient receives both drugs). In this study, the vital blue dye is replaced with VST-1001 and companion medical devices.
VST-1001 is excited by a medical device (blue-light LED illuminator) to fluoresce; the surgeon is wearing blue-light filtering eyewear to improve visualization of the relevant tissue structures.
Single-dose injection (peritumoral, periareolar, and/or intradermal) of VST-1001 administered pre-SLNB procedure; VST-1001 is used with medical devices (blue-light LED illuminator and blue-light filtering eyewear) for lymphatic mapping and localization of lymph nodes during a SLNB procedure.
Other Name: dilute fluorescein
Drug: 99mTc-labeled sulfur colloid
Single-dose injection (peritumoral, periareolar, intradermal, and/or subdermal) of 99mTc-labeled sulfur colloid administered per standard of care; the radioactivity of the radioactive colloid is detected with a gamma probe per standard of care.
- LYMPH NODE-LEVEL CONCORDANCE of Visually Observed VST-1001 Fluorescence and 99mTc-Labeled Sulfur Colloid Radioactivity, where CONCORDANCE is defined relative to radioactive nodes [ Time Frame: The primary outcome is assessed during surgery. ]Fluorescence and radioactivity data will be collected during the SLNB surgical procedure.
- LYMPH NODE-LEVEL REVERSE CONCORDANCE of Visually Observed VST-1001 Fluorescence and 99mTc-Labeled Sulfur Colloid Radioactivity, where REVERSE CONCORDANCE is defined relative to fluorescent nodes [ Time Frame: The secondary outcome is assessed during surgery. ]Fluorescence and radioactivity data will be collected during the SLNB surgical procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294565
|Contact: Maryse Brulotte, BPharm, DESSemail@example.com|
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Dianna L Riall, RN 713-745-0751 DLRiall@mdanderson.org|
|United States, Utah|
|The University of Utah Huntsman Cancer Institute||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Brady Gamble 801-585-0550 firstname.lastname@example.org|
|Study Director:||Robert HI Andtbacka, MD||Vestan, Inc.|
|Principal Investigator:||Merrick I Ross, MD||M.D. Anderson Cancer Center|