NCT02637934 Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
| NCT ID | NCT02637934 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Abramson Cancer Center at Penn Medicine |
| Condition | Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2016-01-14 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 35 participants in total. It began in 2016-01-14 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Fiona Simpkins, MD
PRINCIPAL INVESTIGATOR
Abramson Cancer Center at Penn Medicine
Frequently Asked Questions
Who can join the NCT02637934 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Suspected Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02637934 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02637934 currently recruiting?
Yes, NCT02637934 is actively recruiting participants. Contact the research team at PennCancerTrials@emergingmed.com for enrollment information.
Where is the NCT02637934 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT02637934 clinical trial?
NCT02637934 is sponsored by Abramson Cancer Center at Penn Medicine. The principal investigator is Fiona Simpkins, MD at Abramson Cancer Center at Penn Medicine. The trial plans to enroll 35 participants.
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