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intraoperative imaging camera system for Ovarian Cancer
Phase 1
Waitlist Available
Led By Sunil Singhal
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients > 18 years of age
Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks post surgery (completion of post-operative follow-up visit)
Awards & highlights
Study Summary
This study is evaluating whether a new imaging system can detect ovarian cancer.
Eligible Conditions
- Ovarian Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 weeks post surgery (completion of post-operative follow-up visit)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks post surgery (completion of post-operative follow-up visit)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare the performance of different camera imaging systems in assessing the positive predictive values
Trial Design
1Treatment groups
Experimental Treatment
Group I: OTL 38Experimental Treatment2 Interventions
The study drug in question is an Investigational New Drug (IND), folate analog ligand conjugated with an indole cyanine green-like dye called OTL38. There will be a single dose of 0.025 mg/kg for intravenous injection over approximately 60 minutes, completed at least 1 hour prior to intraoperative imaging
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OTL38
2018
Completed Phase 3
~470
Find a Location
Who is running the clinical trial?
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,135 Total Patients Enrolled
8 Trials studying Ovarian Cancer
961 Patients Enrolled for Ovarian Cancer
Abramson Cancer Center at Penn MedicineLead Sponsor
383 Previous Clinical Trials
144,891 Total Patients Enrolled
8 Trials studying Ovarian Cancer
961 Patients Enrolled for Ovarian Cancer
Sunil SinghalPrincipal InvestigatorUniversity of Pennsylvania
2 Previous Clinical Trials
301 Total Patients Enrolled
1 Trials studying Ovarian Cancer
10 Patients Enrolled for Ovarian Cancer
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