OTL38 Injection (OTL38) for Intra-Operative Imaging of Folate Receptor Positive Ovarian Cancer
NCT04941378 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2022-06-27
Summary
The primary objective of the study is to compare the performance of different camera imaging systems in assessing the positive predictive values and sensitivity of OTL38 to detect folate positive ovarian cancer cancers using the gold standard of pathologic review.
Conditions
Interventions
- DRUG
-
OTL38
One time infusion of OTL38
- DEVICE
-
intraoperative imaging camera system
intraoperative imaging camera system
Sponsors & Collaborators
-
Abramson Cancer Center at Penn Medicine
lead OTHER
Principal Investigators
-
Sunil Singhal · University of Pennsylvania
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-28
- Primary Completion
- 2022-05-28
- Completion
- 2022-05-28
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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