Imaging technique to assess cancer tissue before surgery
PET Biodistribution Study of 68Ga-PSMA-11 and 68Ga-FAPI-46 in Patients With Non-Prostate Cancers: An Exploratory Biodistribution Study With Histopathology Validation
This study is testing a new imaging technique to see how well it can show cancer tissue in patients with different types of cancer before they have surgery.
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 | NCT04147494 on ClinicalTrials.gov |
What this trial studies
This phase I trial investigates a new imaging technique called FAPi PET/CT to evaluate the accumulation of a PET tracer in normal and cancer tissues in patients with various non-prostate cancers. The study aims to correlate the imaging results with the actual tumor tissue that will be surgically removed. Participants may also have the option to undergo an additional imaging scan using a different tracer, PSMA PET/CT, and those who have not had a recent FDG PET/CT will receive that as well. The goal is to enhance the understanding of tumor biology and improve surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates include patients with breast, colon, esophageal, gastric, head and neck, lung, ovarian, pancreatic, renal, or uterine cancers who are scheduled for surgical resection.
Not a fit: Patients who are pregnant or nursing, or those who have received new cancer therapy recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate imaging techniques that improve surgical planning and outcomes for cancer patients.
How similar studies have performed: While this approach is innovative, similar imaging techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with the following cancer types: * Breast cancer * Colon cancer * Esophageal cancer * Gastric cancer * Head and Neck cancer * Lung cancer * Ovarian cancer * Pancreatic cancer * Renal cancer * Uterus cancer * Patients who are scheduled to undergo surgical resection of the primary tumor and/or metastasis * Patient can provide written informed consent * Patient is capable of complying with study procedures * Patient is able to remain still for duration of imaging procedure (up to one hour) 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
- Ethan Lam — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Jeremie Calais, MD — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Ethan Lam
- Email: clam@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.