Imaging breast cancer using a new radioactive tracer
Imaging Using the Novel Radiotracer [18F] FluorThanaTrace([18F]FTT) by PET/CT in Patients with Breast Cancer
This study is testing a new radioactive tracer to see if it can improve imaging for breast cancer patients who are having a biopsy or surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 3 sites (Saint Louis, Missouri and 2 other locations) |
| Trial ID | NCT05226663 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness of the radioactive tracer [18F]FluorThanatrace in improving imaging techniques for patients with breast cancer who are undergoing biopsy or surgery. The study aims to correlate the uptake of [18F]FluorThanatrace in PET/CT scans with established measures of cancer activity, such as PARP-1 immunohistochemistry. Patients will receive the tracer intravenously and undergo imaging scans to assess the tracer's uptake and safety. The trial will also explore the reproducibility of the imaging results through test-retest scans.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with known primary breast cancer and a target lesion size of 1.0 cm or greater.
Not a fit: Patients who are pregnant, breastfeeding, or have received prior therapy for breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of breast cancer imaging, leading to better treatment planning and outcomes for patients.
How similar studies have performed: Other studies using novel imaging agents have shown promise, but the specific use of [18F]FluorThanatrace in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants will be \>= 18 years of age * Known primary breast cancer. For subjects with primary breast cancer we will target lesion size of 1.0 cm or greater on at least one type of standard clinical imaging (e.g. mammogram, ultrasound, breast magnetic resonance imaging \[MRI\]) * A candidate for primary breast surgery (mastectomy or lumpectomy) * Participants must be informed of the investigational nature of this study and provide written informed consent, in accordance with institutional and federal guidelines prior to study-specific procedures Exclusion Criteria: * Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to injection of FTT * Inability to tolerate imaging procedures in the opinion of an investigator or treating physician * Current or prior therapy for the primary breast cancer * 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
Saint Louis, Missouri and 2 other locations
- Siteman Cancer Center at Washington University — Saint Louis, Missouri, United States (Recruiting)
- University of Pennsylvania/Abramson Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
- M D Anderson Cancer Center — Houston, Texas, United States (Suspended)
Study contacts
- Principal investigator: Lilie L Lilie — M.D. Anderson Cancer Center
- Study coordinator: Lilie Lilie
- Email: lllin@mdanderson.org
- Phone: 713) 563-2413
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.