Using a special imaging technique to evaluate breast cancer
Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer
This study is testing a new imaging technique to see how well it works for people with breast cancer and to better understand different types of the disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03863457 on ClinicalTrials.gov |
What this trial studies
This study involves patients with known or suspected breast cancer who have at least one lesion measuring 1.5 cm or larger. Participants will undergo PET/CT imaging with a novel tracer, [18F]F-GLN, to assess its uptake and image quality. The study aims to stratify patients based on breast cancer subtypes, specifically focusing on estrogen-receptor-expressing and triple-negative breast cancers. The results will not directly influence treatment decisions but will provide valuable data on the imaging technique's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with known or suspected primary or metastatic breast cancer and 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 understanding of breast cancer metabolism and improve imaging techniques for better diagnosis and monitoring.
How similar studies have performed: While this approach is novel, similar imaging techniques have shown promise in other cancer types, indicating potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants will be ≥ 18 years of age * Known or suspected primary or metastatic breast cancer. * At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT). Only one type of imaging is required to show a lesion. * Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: * Females who are pregnant or breast feeding at the time of screening; 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
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Austin Pantel, MD — Instructor of Radiology
- Study coordinator: Erin Schubert
- Email: erin.schubert@pennmedicine.upenn.edu
- Phone: 215-573-6569
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.