Exploring a new imaging technique for cancer detection
PET Biodistribution Study of 68Ga-FAPI-46 in Patients With Different Malignancies: An Exploratory Biodistribution Study With Histopathology Validation
PHASE1 · Jonsson Comprehensive Cancer Center · NCT04459273
This study is testing a new imaging method to see how a special tracer used in scans can help detect different types of cancer by showing where it gathers in the body.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center (other) |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT04459273 on ClinicalTrials.gov |
What this trial studies
This exploratory study investigates the use of 68Ga-FAPi-46 PET/CT imaging to assess the distribution of a tracer that targets fibroblast activation protein in various cancer types. The primary objective is to define how this tracer accumulates in both normal and cancerous tissues. Additionally, the study aims to correlate the imaging results with histopathological findings and other imaging techniques like 18F-FDG PET. Patients will receive the tracer intravenously and undergo imaging to gather data on its biodistribution.
Who should consider this trial
Good fit: Ideal candidates include adults with specific types of cancer who are scheduled for surgical resection or biopsy.
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 cancer detection and characterization, leading to better treatment planning.
How similar studies have performed: While the use of FAP-targeting imaging is a novel approach, similar imaging techniques have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with the following cancer types: * Brain cancer * Bladder cancer * Urothelial cancer * Testicular cancer * Skin cancer * Thyroid cancer * Hepatocellular carcinoma * Cholangiocarcinoma * Thymus cancer * Pleural cancer * Cervical cancer * Adrenal cancer * Neuroendocrine tumors * Hematologic cancer * Cancer of Unkown Primary * Patients who are scheduled to undergo surgical resection or tissue biopsy of the primary tumor and/or metastasis * Patients are ≥ 18 years old at the time of the radiotracer administration. * Patient can provide written informed consent * 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 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 — 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.
Conditions: Bladder Carcinoma, Cervical Carcinoma, Cholangiocarcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Hepatocellular Carcinoma, Malignant Adrenal Gland Neoplasm, Malignant Brain Neoplasm, Malignant Pleural Neoplasm