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OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

NCT03180307 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-02-04

Study results available
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Summary

This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.

Conditions

Interventions

DRUG

OTL38

0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes

DEVICE

near infrared camera imaging system

Infrared imaging used to excite OTL38 for fluorescence

PROCEDURE

laparotomy

primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Sponsors & Collaborators

  • SynteractHCR

    collaborator INDUSTRY

  • On Target Laboratories, LLC

    lead INDUSTRY

Principal Investigators

  • Janos Tanyi, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-26
Primary Completion
2020-04-16
Completion
2020-10-16
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT03180307 on ClinicalTrials.gov