Where the 68Ga-FAPi-46 PET tracer goes in adults with solid tumors or blood cancers
PET Imaging Study of 68Ga-FAPI-46 Biodistribution in Cancer Patients
Researchers will test a PET tracer called 68Ga-FAPi-46 to see where it collects in adults with solid tumors or blood cancers.
Quick facts
| Phase | 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 | NCT07118176 on ClinicalTrials.gov |
What this trial studies
This Phase 1 imaging study gives participants an IV dose of 68Ga-FAPi-46 and performs PET/CT scans 20–90 minutes after injection to map tracer uptake across normal organs and tumors. Scans typically take 20–50 minutes and participants may optionally have a standard 18F-FDG PET/CT for comparison. The primary measurements are standardized uptake values (SUVs) to define biodistribution, and secondary analyses compare 68Ga-FAPi-46 and 18F-FDG uptake patterns to classify tumor phenotypes (FAP+/FDG+, FAP-/FDG+, etc.). The trial is conducted at UCLA’s Jonsson Comprehensive Cancer Center and enrolls adults with a wide range of solid or hematologic malignancies who can consent and tolerate imaging.
Who should consider this trial
Good fit: Adults (age ≥18) with suspected or confirmed solid tumors or hematologic cancers who can provide informed consent and lie still for the imaging procedures are ideal candidates.
Not a fit: Patients whose tumors do not take up FAP-targeted tracers, those unable to undergo PET/CT (for example due to severe claustrophobia or inability to remain still), and pregnant women are unlikely to receive direct benefit.
Why it matters
Potential benefit: If successful, this tracer could help doctors better image and characterize many cancers by revealing tumor-associated fibroblast activity that current scans may miss.
How similar studies have performed: Early clinical work with FAPI-targeted PET tracers has shown promising tumor uptake and low background in multiple cancers, though 68Ga-FAPi-46 continues to be characterized in larger groups.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with the following suspected or diagnosed cancer types: * Adrenal cancer * Anal cancer * Bladder cancer * Brain cancer * Breast cancer * Cancer of unknown primary (CUP) * Cervical cancer * Cholangiocarcinoma * Colorectal cancer * Esophageal cancer * Gastric cancer * Head and neck cancer * Hematologic cancer * Hepatocellular carcinoma * Lung cancer * Medullary thyroid cancer * Neuroendocrine neoplasias * Ovarian cancer * Pancreatic cancer * Penile cancer * Peritoneal cancer * Pleural cancer * Prostate cancer * Sarcoma * Salivary gland cancer * Solitary fibrous tumor * Skin cancer * Testicular cancer * Thymus cancer * Thyroid cancer * Urothelial cancer * Uterus cancer * Vaginal cancer * 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 * 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
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.