Ovarian Cancer Clinical Trial
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Summary
Up to 35 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 10 patients and the Dynamic cohort will include up to 20 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.
Full 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 Criteria
Inclusion Criteria for Dynamic cohort
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 for Dynamic cohort
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
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States More Info
Principal Investigator
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