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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
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About this study
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
Study design
Enrollment target: 35 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2016-01-14
Estimated completion: 2026-10
Last updated: 2026-04-07
Interventions
Drug: [18F]FluorThanatraceRadiation: PET/CT imaging sessions
Primary outcomes
  • Number of Adverse Events (3 years)
Sponsor
Abramson Cancer Center at Penn Medicine · other
Contacts & investigators
ContactFiona Simpkins, MD · contact · PennCancerTrials@emergingmed.com · 855-216-0098
InvestigatorFiona Simpkins, MD · principal_investigator, Abramson Cancer Center at Penn Medicine
All locations (1)
Abramson Cancer Center of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT · TrialPath