Recruiting
Phase 1
Phase 2

VST-1001

Sponsor:

Vestan, Inc.

Code:

NCT02294565

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VST-1001

99mTc-labeled sulfur colloid

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT02294565

Start date

Jun, 2014

Status verified date

Jul, 2015

Completion date

May, 2016

Anticipated

Primary completion date

Jan, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of primary breast cancer.
  • Diagnosed with invasive adenocarcinoma, or DCIS for which a SLNB is the recommended standard of care, or breast cancer with all of the following conditions met:

  • FNA results positive for cancer cells
  • positive clinical breast examination
  • mammography and/or US and/or MRI abnormality(ies) consistent with malignancy.
  • N0 and M0 at the time of study entry.
  • ECOG 0, 1, or 2

Exclusion Criteria:

  • A tumor with direct extension to the chest wall and/or to the skin.
  • Diffuse tumors or multiple malignant tumors in the breast.
  • Prior breast malignancy of the ipsilateral breast.
  • Patient currently receiving or had prior treatment for the currently diagnosed breast cancer.
  • Medical conditions and/or prior surgical procedures that have the potential to substantially alter the lymphatic drainage pattern from the primary tumor to the lymph node basin.
  • Inability to localize 1 or 2 lymph node drainage basin(s) via lymphatic mapping.

Study Design

Enrollment

147 participants

Anticipated

Intervention Model

Single group

Interventions and Outcome Measures

Arms

other: 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.

Interventions

VST-1001

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.

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Maryse Brulotte, BPharm, DESS

801-983-6448maryse.brulotte@vestanmed.com

Locations

The University of Texas M.D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Dianna L Riall, RN

713-745-0751DLRiall@mdanderson.org

The University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Brady Gamble

801-585-0550brady.gamble@hci.utah.edu

More Information

Sponsor

Vestan, Inc.

Last update posted

Jul 27, 2015

Last verified

Jul, 2015

Keywords

  • Sentinel Lymph Node Biopsy
  • Breast Cancer
  • Lymphatic Mapping

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vestan, Inc. on 2015-07-27.