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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 up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met