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

NCT02637934•Abramson Cancer Center at Penn Medicine

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

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Participants will be ≥ 18 years of age
•History of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer (may have primary or recurrent cancer at the time of study enrollment)
•At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, ultrasound, FDG PET/CT)

Exclusion Criteria

•Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential at screening.
•Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
•Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

Locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

January 14, 2016

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2026

Last Updated

September 10, 2025

Enrollment

ESTIMATED participants

Conditions

Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Interventions

[18F]FluorThanatrace

DRUG

PET/CT imaging sessions

RADIATION

Contacts

Fiona Simpkins, MD

CONTACT

855-216-0098 PennCancerTrials@emergingmed.com