Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT02637934
Brief Summary:
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
Study:
NCT02637934
Study Brief:
Protocol Section:
NCT02637934