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

Study results available
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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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02317705 on ClinicalTrials.gov