Imaging Tracer 68Ga-FAPi-46 for Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Pregnancy, Nursing, Underlying disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging tracer, Gallium Ga 68 FAPi-46, to observe its visibility in normal and cancerous tissues. The tracer is used with PET/CT scans, which help doctors locate cancer in the body. This method could improve cancer detection and understanding of disease spread. Individuals with any type of solid or blood cancer, such as breast or lung cancer, who can remain still for about an hour during the scan, might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new imaging tracer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this imaging tracer is safe?

Research has shown that the imaging tracer 68Ga-FAPi-46 is safe for humans. In one study, six patients received the tracer and experienced no side effects, suggesting its safety for imaging use. The tracer aids doctors in identifying cancerous areas through PET/CT scans, which combine two imaging methods for a clear picture. Although still under testing, these early findings indicate promising safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Gallium Ga 68 FAPi-46 because it offers a new way to image cancer. Unlike traditional imaging methods, which often use FDG PET/CT scans, this tracer targets fibroblast activation protein (FAP) present in cancer-associated fibroblasts. This could potentially provide clearer images of tumors and their environments. By homing in on FAP, Gallium Ga 68 FAPi-46 may enable more precise tumor detection and help in better tailoring cancer treatments.

What evidence suggests that this imaging tracer is effective for detecting cancer?

Research shows that the imaging tracer 68Ga-FAPi-46, which participants in this trial will receive, holds promise for detecting cancerous tissues. Studies have found that various cancers, such as pancreatic and esophageal, can absorb this tracer. This absorption aids doctors in visualizing these cancers using PET/CT scans. The tracer accumulates in cancer cells by targeting cancer-associated fibroblasts, which often surround tumors. Previous findings suggest that the tracer provides clear images of cancer location and spread. Overall, 68Ga-FAPi-46 enhances doctors' ability to view cancer within the body. ^{5 6 7 8 9}

Who Is on the Research Team?

Jeremie Calais

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with various solid tumors or blood cancers. It's designed to test a new imaging tracer called 68Ga-FAPi-46 using PET/CT scans. Participants should have a confirmed diagnosis of one of the listed cancers and be suitable for PET/CT imaging.

Inclusion Criteria

Patient can provide written informed consent

I am 18 years old or older.

I can stay still for up to an hour for a scan.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive 68Ga-FAPi-46 intravenously and undergo PET/CT to evaluate biodistribution

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Gallium Ga 68 FAPi-46

Trial Overview The study is evaluating how well the new tracer, 68Ga-FAPi-46, shows up in cancerous and normal tissues during PET/CT scans. This phase I trial aims to understand the distribution of this tracer within the body to improve cancer detection.

How Is the Trial Designed?

Group I: Diagnostic (68Ga-FAPi-46 PET/CT) Experimental Treatment 4 Interventions

Patients receive 68Ga-FAPi-46 IV and then, 20-90 minutes later, undergo PET/CT over 20-50 minutes. Patients may undergo optional 18F-FDG PET/CT on study.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6424229/

68Ga-FAPI PET/CT: Biodistribution and Preliminary ... The effective dose for 68Ga-FAPI-4 PET/CT was 1.64E−2 mSv/MBq calculated ... We found high 68Ga-FAPI uptake in pancreatic cancer, esophageal cancer ...

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12461-w

Diagnostic accuracy and clinical value of [68Ga]Ga-FAPI-46 ... In 2018, the first results of [68Ga]Ga-FAPI PET/CT were published, with promising results both in animal cancer models and in cancer patients [ ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05518903

NCT05518903 | Investigational Scan (68Ga-FAPI-46 PET/ ... This phase II trial tests whether 68Ga-FAPI-46 positron emission tomography (PET)/computed tomography (CT) scan works to image cancer-associated fibroblasts ...

4. ejnmmipharmchem.springeropen.com ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-025-00375-2

Preclinical evaluation of [68Ga]Ga-AAZTA-FAPI-46: a ... Results. Gallium-68 radiolabelling was achieved with high radiochemical yield at room temperature. The new tracer was stable in different media, ...

5. nature.com nature.com/articles/s41598-023-43049-2

Comparison of early and late 68Ga-FAPI-46-PET in 33 ... Early and late acquisition of 68 Ga-FAPI-PET results in comparable imaging information in patients with possible recurrence of PDAC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7413240/

Radiation Dosimetry and Biodistribution of 68Ga-FAPI-46 ... The tracer injection was well tolerated without any side effects in all 6 patients.

7. jnm.snmjournals.org jnm.snmjournals.org/content/64/8/1232

Tumor Characterization by [ 68 Ga]FAPI-46 PET/CT Can ... We conclude that [ 68 Ga]FAPI-46 PET/CT can accurately differentiate malignant from benign pancreatic lesions deemed equivocal by standard-of-care imaging.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04457258

NCT04457258 | 68Ga-FAPi-46 PET/CT Scan in Imaging ... This early phase I trial studies an imaging technique called 68Ga-FAPi-46 PET/CT to determine where and to which degree the FAPI tracer (68Ga-FAPi-46) ...

9. cancerimagingjournal.biomedcentral.com cancerimagingjournal.biomedcentral.com/articles/10.1186/s40644-025-00886-w

68Ga-FAPI-46 PET derived texture parameters improve the ... 68 Ga-FAPI-46 PET texture parameters show great potential to differentiate between lung cancer and benign pulmonary lesions inconclusive in 18 F-FDG/PET.