Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
- Conditions
- Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- Interventions
- Radiation: PET/CT imaging sessions
- Registration Number
- NCT02637934
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
Up to 40 evaluable women with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer will participate in two different imaging cohorts. The Biodistribution cohort will include up to 4 patients and the Dynamic cohort will include up to 36 patients. Human dosimetry will be calculated from the Biodistribution cohort. The Dynamic cohort date will evaluate preliminary information on uptake of \[18F\]FTT in gynecological cancer and compare with PARP-1 activity in tissue.
- Detailed Description
Primary Objectives
• Evaluate PARP-1 activity in epithelial ovarian, fallopian tube, or primary peritoneal cancer using measures of uptake of \[18F\]FluorThanatrace
Secondary Objectives
* Evaluate the safety of \[18F\]FluorThanatrace
* Correlate \[18F\]FluorThanatrace uptake measures with BRCA mutation status
* Correlate \[18F\]FluorThanatrace uptake measures with PARP-1 activity in tumor.
* Determine biodistribution of the radioactive investigational drug (\[18F\]FluorThanatrace) in patients and calculate human dosimetry.
* Evaluate change in \[18F\]FluorThanatrace uptake measures after therapy
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dynamic [18F]FluorThanatrace 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. Dynamic PET/CT imaging sessions 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. Biodistribution PET/CT imaging sessions 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. Biodistribution [18F]FluorThanatrace 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.
- Primary Outcome Measures
Name Time Method Number of Adverse Events 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States