Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03113825|
Recruitment Status : Active, not recruiting
First Posted : April 14, 2017
Last Update Posted : April 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Primary Invasive Malignant Neoplasm of Female Breast Carcinoma Breast Breast Cancer Female Carcinoma, Ductal, Breast Stage II Breast Cancer Stage I Breast Cancer Stage III Breast Cancer||Device: Investigational Imaging device Drug: AVB-620||Phase 2|
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent, nonmetastatic breast cancer undergoing either a lumpectomy with simultaneous sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND), or a mastectomy and simultaneous ALND. AVB-620 is a synthetic protease-activated peptide dye conjugate administered intravenously for the fluorescence detection and localization of potentially malignant tissue in primary tumor, tumor margins, or lymph nodes. A fluorescence image will be displayed on a monitor and will assist the surgeon to assess potentially cancerous tissue within the primary tumor site, tumor margins, or in lymph nodes which drain the primary tumor site.
Eligible patients will receive a single dose of AVB-620 by IV infusion up to 24 hours prior to breast surgery.
The study will evaluate the effect of timing of AVB-620 administration relative to surgery on the fluorescence and the accuracy of the AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Period 1 will enroll approximately 35 patients to evaluate conditions to achieve maximal differences in fluorescent signals between malignant and nonmalignant tissue. Period 2 will enroll approximately 120 patients to test dosing and imaging conditions determined in Period 1 and accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery|
|Actual Study Start Date :||July 5, 2017|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: AVB-620 & Investigational Imaging Device
Eligible subjects will receive a single dose of AVB-620 as intravenous infusion before the surgical procedure. During the surgical procedure, fluorescent imaging will be undertaken to distinguish between malignant and nonmalignant tissues.
Device: Investigational Imaging device
Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.
Other Name: Fluorescent Imaging Camera
AVB-620 will be administered IV before the surgical procedure.
Other Name: Investigational Drug
- Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues. [ Time Frame: 1 month ]Determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients.
- Safety of AVB-620 as assessed by incidence of adverse events and abnormal laboratory values. [ Time Frame: 1 month ]Evaluate the safety and tolerability of a single AVB-620 infusion in women undergoing breast cancer surgery.
- Identify malignant tissue types that provide the most robust fluorescence response compared to non-malignant tissue. [ Time Frame: 1 month ]Measure fluorescence intensity differences between malignant and non-malignant tissue to identify best responding tissue type.
- Evaluate timing of AVB-620 administration on optical fluorescence characteristics [ Time Frame: 1 month ]Further evaluate the effect of the timing of AVB-620 administration on the optical fluorescence characteristics
- Evaluate imaging techniques and conditions [ Time Frame: 1 month ]Evaluate the impact of changes in intraoperative imaging techniques and conditions in distinguishing malignant from nonmalignant tissue compared to pathological assessment.
- Evaluate methods for image analysis and display [ Time Frame: 1 month ]Evaluate and refine methods and criteria by which images are analyzed and displayed
- Evaluate breast cancer patient suitability for AVB-620 imaging [ Time Frame: 1 month ]Evaluate which breast cancer patients are most suitable for AVB-620 imaging
- Determine re-excision rates [ Time Frame: 4 weeks ]Determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.
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): NCT03113825
|United States, California|
|San Diego, California, United States, 92093|
|United States, District of Columbia|
|Medstar Washington Hospital|
|Washington, District of Columbia, United States, 200010|
|United States, Florida|
|Mayo Clinic Jacksonville -- Center for Breast Health|
|Jacksonville, Florida, United States, 32224|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|United States, Illinois|
|Advocate Good Shepherd Hospital|
|Barrington, Illinois, United States, 60010|
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|United States, Nevada|
|UNLV School of Medicine|
|Las Vegas, Nevada, United States, 89102|
|United States, New York|
|Montefiore Einstein Center for Cancer Care|
|Bronx, New York, United States, 10461|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|Ohio State University, James Cancer Center|
|Columbus, Ohio, United States, 43210|
|United States, South Carolina|
|Roper St. Francis Hospital|
|Charleston, South Carolina, United States, 29401|
|United States, Washington|
|Swedish Cancer Institute|
|Seattle, Washington, United States, 98104|
|Study Director:||Steven Chen, MD, MBA||Avelas Biosciences, Inc.|