Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
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|ClinicalTrials.gov Identifier: NCT03113825|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : February 27, 2019
|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)|
|Estimated Enrollment :||110 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 :||September 2019|
|Estimated Study Completion Date :||December 2019|
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
|Contact: Melody Anderson, M.S.||firstname.lastname@example.org|
|Contact: Christy Romanowskiemail@example.com|
|United States, Arizona|
|Scottsdale, Arizona, United States, 85054|
|Contact: Sherilyn Faulkner 480-342-6429 Faulkner.Sherilyn@mayo.edu|
|Contact: Leslie Alfieri (480) 342-6048 Alfieri.firstname.lastname@example.org|
|Principal Investigator: Barbara Pockaj, MD|
|United States, California|
|San Diego, California, United States, 92093|
|Contact: Jill McCarthy 858-822-4516 email@example.com|
|Contact: Sara Neugroschl (858) 822-7952 firstname.lastname@example.org|
|Principal Investigator: Anne Wallace, MD|
|United States, Florida|
|Mayo Clinic Jacksonville -- Center for Breast Health||Recruiting|
|Jacksonville, Florida, United States, 32224|
|Contact: Amanda Arnold 904-953-3652 email@example.com|
|Principal Investigator: Sarah McLaughlin, MD|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Deanna Hogue 813-745-8304 firstname.lastname@example.org|
|Contact: Yvonne Gorham 813-745-4027 email@example.com|
|Principal Investigator: Marie-Catherine Lee, MD|
|United States, New York|
|Montefiore Einstein Center for Cancer Care||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Zarema Jagizarov 718-920-4747 firstname.lastname@example.org|
|Principal Investigator: Sheldon Feldman, MD|
|Sub-Investigator: Maureen McEvoy, MD|
|Sub-Investigator: Paul Baron, MD|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Karen Rudnicki 716-845-4066 Karen.Rudnicki@RoswellPark.org|
|Contact: Heather Cameron (716) 845-1780 Heather.Cameron@RoswellPark.org|
|Principal Investigator: Kazuaki Takabe, MD|
|United States, Ohio|
|University Hospitals Cleveland Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Lauren L Hricik 216-844-5176 Lauren.Hricik@UHhospitals.org|
|Contact: Michelle Cortez 216-896-1787 ext 2 Michelle.Cortez@UHhospitals.org|
|Principal Investigator: Jill R Dietz, MD|
|Ohio State University, James Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Rachel Hoecherl 614-293-7823 Rachel.email@example.com|
|Contact: Lynette Mesi 614-293-6669 Lynette.Mesi@osumc.edu|
|Principal Investigator: Valerie Grignol, MD|
|United States, South Carolina|
|Roper St. Francis Hospital||Completed|
|Charleston, South Carolina, United States, 29401|
|Study Director:||Steven Chen, MD, MBA||Avelas Biosciences, Inc.|