Evaluating a new radiotracer for imaging ovarian cancer
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
This study is testing a new imaging agent to see if it can safely help women with ovarian cancer better understand their tumors and how they relate to certain genetic factors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT02637934 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves up to 40 women with known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants will be divided into two imaging cohorts: a Biodistribution cohort for dosimetry calculations and a Dynamic cohort to assess the uptake of the novel radiotracer [18F]FluorThanatrace (FTT) in relation to PARP-1 activity in tumors. The study aims to evaluate the safety of FTT and its correlation with BRCA mutation status and tumor activity. PET/CT imaging sessions will be utilized to gather data on the biodistribution and metabolism of the radiotracer.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a history of known or suspected epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Not a fit: Patients who are pregnant, breastfeeding, or unable to tolerate imaging procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of imaging techniques for diagnosing and monitoring ovarian cancer.
How similar studies have performed: While this approach is novel, similar studies using radiotracers for cancer imaging have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Fiona Simpkins, MD — Abramson Cancer Center at Penn Medicine
- Study coordinator: Fiona Simpkins, MD
- Email: PennCancerTrials@emergingmed.com
- Phone: 855-216-0098
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.