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[18F]FluorThanatrace PET/CT Imaging for Ovarian Cancer

Phase 1
Recruiting
Led By Fiona Simpkins, MD
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
Participants will be ≥ 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Study Summary

This trial is testing a new imaging technique to see how well it works in women with ovarian cancer.

Who is the study for?
This trial is for women aged 18 or older with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer. They must have at least one lesion that's visible on standard imaging and can be either newly diagnosed or have recurrent cancer. Pregnant or breastfeeding women and those unable to tolerate imaging procedures are excluded.Check my eligibility
What is being tested?
[18F]FluorThanatrace (FTT) is being tested in this study using PET/CT scans to understand its distribution, metabolism, and excretion in patients with gynecological cancers. The trial has two parts: a Biodistribution cohort for dosimetry calculations and a Dynamic cohort to assess FTT uptake compared to PARP-1 activity in tissues.See study design
What are the potential side effects?
As the intervention involves diagnostic imaging rather than treatment drugs, side effects may include discomfort from lying still during the PET/CT scan and exposure to radiation typical of such medical imaging procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Adverse Events

Trial Design

2Treatment groups
Experimental Treatment
Group I: DynamicExperimental Treatment2 Interventions
The Dynamic cohort will include up to 36 patients who will undergo 1 static skull base to mid-thigh scans imaging post injection of [18F]FTT.
Group II: BiodistributionExperimental Treatment2 Interventions
The Biodistribution cohort will include up to 4 patients who will undergo a series of vertex to mid-thigh biodistribution [18F]FTT PET/CT scans over a period of approximately 4 hours. Up to 10 subjects were initially planned for this cohort, however, the first 4 subjects have been enrolled and initial data analysis for these completed. The decision was made to close enrollment for this cohort as we do not believe that we need to complete the up to 10 subjects originally planned for this cohort as the initial data shows consistent and repeatable data that we do not believe would change significantly with the addition of 6 more subjects.

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
104,963 Total Patients Enrolled
9 Trials studying Ovarian Cancer
961 Patients Enrolled for Ovarian Cancer
Abramson Cancer Center at Penn MedicineLead Sponsor
390 Previous Clinical Trials
145,896 Total Patients Enrolled
9 Trials studying Ovarian Cancer
961 Patients Enrolled for Ovarian Cancer
Fiona Simpkins, MDPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
2 Previous Clinical Trials
92 Total Patients Enrolled

Media Library

[18F]FluorThanatrace Clinical Trial Eligibility Overview. Trial Name: NCT02637934 — Phase 1
Ovarian Cancer Research Study Groups: Biodistribution, Dynamic
Ovarian Cancer Clinical Trial 2023: [18F]FluorThanatrace Highlights & Side Effects. Trial Name: NCT02637934 — Phase 1
[18F]FluorThanatrace 2023 Treatment Timeline for Medical Study. Trial Name: NCT02637934 — Phase 1
~3 spots leftby Jun 2025
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