Imaging with a new radioactive tracer for solid tumors
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT
This study is testing a new imaging method using a special radioactive tracer to see if it can help find tumor cells in patients with solid tumors like ovarian and breast cancers, while also looking at how safe it is and how it relates to certain genetic factors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03604315 on ClinicalTrials.gov |
What this trial studies
This phase I trial evaluates the effectiveness of fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) in detecting tumor cells in patients with various solid tumors, including ovarian and breast cancers. The study aims to assess the safety of the tracer and its correlation with genetic factors such as BRCA mutation status and PARP-1 activity. Patients will undergo imaging scans before and after treatment initiation to monitor changes in tracer uptake, providing insights into tumor behavior and treatment response.
Who should consider this trial
Good fit: Ideal candidates include patients with known or suspected solid tumors who have at least one measurable lesion.
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 detection and monitoring of solid tumors, leading to improved treatment strategies for patients.
How similar studies have performed: Other studies using novel imaging agents have shown promise, but this specific approach with fluorine F 18 fluorthanatrace is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of known or suspected solid tumor. * At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computed tomography \[CT\], magnetic resonance imaging \[MRI\], ultrasound, fludeoxyglucose \[FDG\] PET/CT). Exclusion Criteria: * 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 \< 2 weeks prior to screening as standard of care. * 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
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Lilie L Lin — M.D. Anderson Cancer Center
- Study coordinator: Lilie Lin
- Email: lllin@mdanderson.org
- Phone: 713-563-2300
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.