NCT02637934|Active Not RecruitingPhase 1DMC
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Sponsor study identifier
interventional
35
1 country
1
Study Start
January 14, 2016
Actual (reported)Primary Completion
August 28, 2026
Actual (reported)Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2015
Actual (reported)December 22, 2015
Actual (reported)January 14, 2016
Actual (reported)August 28, 2026
Actual (reported)August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of Adverse Events
3 years
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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.
Fiona Simpkins, MD
Abramson Cancer Center at Penn Medicine
35 participants (actual enrollment reported by the registry).
First Submitted
December 18, 2015
First Posted
December 22, 2015
Study Start
January 14, 2016
Actual (reported)FTT PET/CT in Metastatic Prostate Cancer
Contact the study team to confirm eligibility.
Primary Completion
August 28, 2026
Actual (reported)Study Completion
August 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 2, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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