Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma, Ductal

Carcinoma, Ductal, Breast

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

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.

Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.

Investigational Imaging device

AVB-620 will be administered IV before the surgical procedure.

AVB-620

Steven Chen, MD, MBA

Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.

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.

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.

Women with DCIS or Stage I-III breast cancer who are undergoing lumpectomies or mastectomies and sentinel lymph node biopsies or axillary lymph node dissection.

Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

An Open-Label, Single-Arm, Phase 2 Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Evaluate the impact of changes in intraoperative imaging techniques and conditions in distinguishing malignant from nonmalignant tissue compared to pathological assessment.

Evaluate and refine methods and criteria by which images are analyzed and displayed

Evaluate which breast cancer patients are most suitable for AVB-620 imaging

Determine the planned and actual re-excision rates within 4 weeks after AVB-620 administration.

Determine the accuracy of AVB-620 in correlating image-identified malignant breast or lymph node tissue with pathology findings in breast cancer patients.

Evaluate the safety and tolerability of a single AVB-620 infusion in women undergoing breast cancer surgery.

Measure fluorescence intensity differences between malignant and non-malignant tissue to identify best responding tissue type.

Further evaluate the effect of the timing of AVB-620 administration on the optical fluorescence characteristics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery	NCT03113825	Primary Invasiv... Carcinoma Breas... Breast Cancer F... Carcinoma, Duct... Stage II Breast... Stage I Breast ... Stage III Breas...	Investigational... AVB-620	18 Years -	Avelas Biosciences, Inc.
Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery	NCT03113825	Primary Invasiv... Carcinoma Breas... Breast Cancer F... Carcinoma, Duct... Stage II Breast... Stage I Breast ... Stage III Breas...	Investigational... AVB-620	18 Years -	Avelas Biosciences, Inc.

Spots Global Cancer Trial Database for investigational imaging device