Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
NCT02317705 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2022-06-21
Summary
This study is being done to:
* test the safety of OTL38
* see if OTL38 helps light up the cancer when viewed with the special camera system
* test the safety of the special camera system for use along with OTL38 during surgery
Conditions
Interventions
- DRUG
-
OTL38
- DEVICE
-
Near infrared camera imaging system
Near infrared camera imaging system
- PROCEDURE
-
Laparotomy
primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
Sponsors & Collaborators
-
SynteractHCR
collaborator INDUSTRY -
On Target Laboratories, LLC
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-31
- Primary Completion
- 2015-11-30
- Completion
- 2015-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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