NCT02637934

Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	[18F]FluorThanatrace
RADIATION	PET/CT imaging sessions

Timeline

• Start date: 2016-01-14
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2015-12-22
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States