Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [18F]FluorThanatrace, PET/CT imaging sessions.
- Who it may be relevant to
- Registry conditions: Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug [18F]FluorThanatrace
- Radiation PET/CT imaging sessions
Primary outcome measures
- Number of Adverse Events [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia
Publications
- Makvandi M, Pantel A, Schwartz L, Schubert E, Xu K, Hsieh CJ, Hou C, Kim H, Weng CC, Winters H, Doot R, Farwell MD, Pryma DA, Greenberg RA, Mankoff DA, Simpkins F, Mach RH, Lin LL. A PET imaging agent for evaluating PARP-1 expression in ovarian cancer. J Clin Invest. 2018 May 1;128(5):2116-2126. doi: 10.1172/JCI97992. Epub 2018 Apr 16. PMID 29509546
Identifiers
NCT: NCT02637934 · UPCC 18815