Imaging technique using 68Ga-FAPi-46 PET/CT for patients with sarcoma
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Sarcoma: An Exploratory Biodistribution Study With Histopathology Validation
This study is testing a new imaging method using a special tracer to see how it spreads in healthy and cancerous tissues in patients with sarcoma.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04457258 on ClinicalTrials.gov |
What this trial studies
This early phase I trial investigates the use of 68Ga-FAPi-46 PET/CT imaging to assess the distribution of a specific tracer in normal and cancerous tissues of patients diagnosed with sarcoma. The primary objective is to define how the tracer accumulates in these tissues, validated by histopathology. Secondary objectives include evaluating the correlation between the tracer's accumulation and FAP expression, as well as comparing it with standard imaging techniques like 18F-FDG PET/CT. Patients will receive the tracer intravenously and undergo imaging procedures to gather data on biodistribution and tumor characteristics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for surgical excision or biopsy of suspected sarcoma.
Not a fit: Patients who are pregnant, nursing, or have recently undergone cancer therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of sarcoma imaging, leading to better diagnosis and treatment planning for patients.
How similar studies have performed: While this approach is novel in the context of sarcoma, similar imaging techniques have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are scheduled to undergo surgical excision or biopsy of a suspected sarcoma primary, or a suspected recurrent or metastatic lesion. * Patients who are ≥ 18 years old at the time of the radiotracer administration. * Patients who can provide written informed consent. * Patients who are able to remain still for duration of imaging procedures (up to one hour for each). Exclusion Criteria: * Patient is pregnant or nursing. * Patients with any new cancer therapy between the baseline 18F-FDG PET/CT and the investigational FAPI PET/CT * Patient has underlying disease which, based on the judgment of the investigator, might interfere with the collection of high quality data.
Where this trial is running
Los Angeles, California
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeremie Calais, MD — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Ethan Lam
- Email: eclam@mednet.ucla.edu
- Phone: 310-206-7372
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.