Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT

Launched by ABRAMSON CANCER CENTER AT PENN MEDICINE · Dec 18, 2015

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging agent called [18F]Fluorthanatrace (FTT) to see how it works in women with suspected ovarian, fallopian tube, or primary peritoneal cancer. The goal is to understand how this agent spreads in the body, how it is broken down, and how it is removed, which could help doctors learn more about these types of cancers. The study is open to women aged 18 and older who have either a known or suspected diagnosis of these cancers and have at least one tumor that is 1 cm or larger.

If you decide to participate, you will undergo imaging tests to help researchers gather important information about how well the FTT agent works in identifying cancer. The study will include up to 40 women, with some focusing on how the agent is distributed in the body and others looking at how it interacts with cancer tissue. It’s important to note that pregnant or breastfeeding women cannot participate, and those with certain medical conditions that may affect safety are also excluded. This trial is still recruiting participants, so if you meet the eligibility criteria, you could play a vital role in advancing cancer research!

Gender

FEMALE

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