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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.
Primary Objectives
• Evaluate PARP-1 activity in epithelial ovarian, fallopian tube, or primary peritoneal cancer using measures of uptake of [18F]FluorThanatrace
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biodistribution | Experimental | The Biodistribution cohort will include up to 4 patients who will undergo a series of vertex to mid-thigh biodistribution [18F]FTT PET/CT scans over a period of approximately 4 hours. Up to 10 subjects were initially planned for this cohort, however, the first 4 subjects have been enrolled and initial data analysis for these completed. The decision was made to close enrollment for this cohort as we do not believe that we need to complete the up to 10 subjects originally planned for this cohort as the initial data shows consistent and repeatable data that we do not believe would change significantly with the addition of 6 more subjects. |
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| Dynamic | Experimental | The Dynamic cohort will include up to 36 patients who will undergo 1 static skull base to mid-thigh scans imaging post injection of [18F]FTT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]FluorThanatrace | Drug |
| ||
| PET/CT imaging sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 3 years |
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Inclusion Criteria for Dynamic cohort
Exclusion Criteria for Dynamic cohort
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fiona Simpkins, MD | Contact | 855-216-0098 | PennCancerTrials@emergingmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Fiona Simpkins, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29509546 | Derived | 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. |
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| Radiation |
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