Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Study Details
Study Description
Brief Summary
Up to 35 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 10 patients and the Dynamic cohort will include up to 20 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Biodistribution 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. |
Drug: [18F]FluorThanatrace
Radiation: PET/CT imaging sessions
|
| Experimental: Dynamic The Dynamic cohort will include up to 31 patients who will undergo approximately 60 minutes of dynamic scanning followed by up to 1 static skull base to mid-thigh scans imaging post injection of [18F]FTT. |
Drug: [18F]FluorThanatrace
Radiation: PET/CT imaging sessions
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events [3 years]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
Investigators
- Principal Investigator: Fiona Simpkins, MD, Abramson Cancer Center of the University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 18815