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Intraoperative Tumor Detection Using a Ratiometric Activatable Fluorescent Peptide: A First-in-Human Phase 1 Study
Jonathan T Unkart1, Steven L Chen2, Irene L Wapnir3
1Department of Surgery, Moores Cancer Center, University of California, San Diego, La Jolla, CA, USA.
Annals of Surgical Oncology
|July 13, 2017
Summary
A novel peptide, AVB-620, shows promise for improving breast cancer surgery by enabling real-time intraoperative tumor detection. This first-in-human trial found the agent to be safe and effective in distinguishing malignant from healthy tissue.
Area of Science:
- Oncology
- Surgical Oncology
- Biomedical Imaging
Background:
- Positive surgical margins are a persistent challenge in breast cancer surgery.
- A novel ratiometric activatable cell-penetrating peptide (AVB-620) was evaluated for intraoperative use.
- This study reports the first human trial of AVB-620 in breast cancer surgery.
Purpose of the Study:
- To assess the safety and efficacy of AVB-620 for intraoperative tumor detection in breast cancer surgery.
- To determine the optimal dose of AVB-620 for imaging-guided surgery.
- To evaluate the correlation between AVB-620 imaging and histopathologic findings.
Main Methods:
- A Phase 1, multi-institutional trial with dose escalation and expansion cohorts was conducted.
- Patients received AVB-620 infusion prior to lumpectomy/mastectomy and sentinel lymph node biopsy/axillary dissection.
- Imaging analysis of surgical fields and specimens was correlated with pathology reports.
Main Results:
- Twenty-seven patients received AVB-620 without attributable adverse events or laboratory abnormalities.
- An 8-mg dose of AVB-620 was selected based on imaging data from the dose-escalation cohort.
- Region-of-interest (ROI) imaging analysis demonstrated measurable differences between tumor-positive and tumor-negative tissues.
Conclusions:
- Intraoperative imaging with AVB-620 facilitated real-time tumor detection in surgical specimens.
- AVB-620 is safe and shows potential to enhance the intraoperative identification of malignant tissue during breast cancer operations.
