68Ga-FAPI-46 PET/CT for Crohn's Disease

(FAPI-PETCD Trial)

Overseen By Yong S Lee

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Breastfeeding, Hypersensitivity, others

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

Compensation: Varies

Number of Visits: 1

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method using a special tracer, 68Ga-FAPI-46, to detect changes in the small intestine caused by Crohn's disease. The goal is to determine if this tracer can identify early signs of fibrosis (tissue thickening) before it becomes severe. Participants will be divided into two groups: those with strictures (narrowed areas) in their intestines and those without. Individuals diagnosed with small bowel Crohn's disease who have recently undergone certain imaging tests might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how this new imaging method works in people, offering participants the opportunity to be among the first to benefit from this innovative approach.

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 coordinators or your doctor.

What prior data suggests that the 68Ga-FAPI-46 PET/CT is safe for detecting Crohn's disease?

Research shows that the PET radiotracer 68Ga-FAPI-46, used in this study, is still undergoing safety testing in humans. Limited information exists on how well people tolerate it or what side effects might occur. However, as an early phase trial, the treatment has shown enough promise in labs or initial tests to warrant human trials. While unknown risks may exist, the trial closely monitors safety. Prospective participants should discuss any concerns with the study team or their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Ga68-FAPI-46 for Crohn's Disease because it offers a novel way to understand and diagnose the condition. Unlike traditional treatments that focus on reducing inflammation and managing symptoms, this new approach uses a radioactive tracer that targets fibroblast activation protein (FAP), which is linked to inflammation in Crohn's. This innovative PET/CT imaging technique could provide a clearer picture of disease activity, potentially leading to more tailored and effective treatment plans for patients.

What evidence suggests that 68Ga-FAPI-46 PET/CT is effective for detecting fibrostenosing Crohn's disease?

Research has shown that 68Ga-FAPI-46 PET/CT is promising for detecting a type of Crohn's disease that causes thickening and scarring in the intestines. This special imaging method uses a tracer that attaches to a protein linked to these changes. Studies have found that this technique can highlight areas of disease activity by showing where this protein is active. In this trial, participants will receive a PET/CT scan with 68Ga-FAPI-46 to assess its effectiveness in identifying thickened and scarred tissue in the intestines. Early results suggest that this method could help spot these changes before they lead to narrowing of the intestines. ^{1 6 7 8 9}

Who Is on the Research Team?

David J Bartlett

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Adults over 18 with diagnosed small bowel Crohn's disease, who've had a recent MR or CT enterography. Participants must be able to consent and are divided into two groups: those with small bowel strictures (cases) and those without (controls).

Inclusion Criteria

I've had a special MRI or CT scan of my intestines within the last 3 months.

I have been diagnosed with Crohn's disease in my small intestine.

I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PET/CT Scan

Participants undergo PET/CT scan with 68Ga-FAPI-46 to detect fibrostenosing Crohn's disease

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the PET/CT scan

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ga68-FAPI-46

Trial Overview

The trial is testing if the PET radiotracer 68Ga-FAPI-46 can identify fibrostenosing Crohn's disease in the small intestine by detecting early fibrosis. It compares tracer uptake in patients with and without strictures.

How Is the Trial Designed?

Group I: A group of participants getting PET/CT scan with 68Ga-FAPI-46 Experimental Treatment 1 Intervention

Ga68-FAPI-46 radioactive tracer binding to FAP

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07273188

68Ga-FAPI-46 PET/CT for Assessing Small Bowel ...

This study is a prospective, case-control study evaluating whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's disease in the small bowel ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41483304/

68Ga-FAPI PET/CT for non-invasive characterization and ...

68 Ga-FAPI-46-PET/CT appears promising for assessing disease activity in terms of fibroblast activation in both CD and UC.

3.

scholarsinmedicine.com

scholarsinmedicine.com/latest-news/1429

68Ga-FAPI-46-PET/CT Imaging Shows Promise for ...

For study purposes, data from 43 IBD patients and 43 control patients were examined by 68Ga-FAPI-46-PET/CT. FAPI-positive gastrointestinal (GI) ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06604260

NCT06604260 | FAPi-PET Imaging of in Vivo Fibrosis ...

Our main objective is to evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD. To this end, we will determine 68Ga ...

5.

pubs.acs.org

pubs.acs.org/doi/10.1021/acsptsci.4c00641

Fibroblast Activation Protein Inhibitor (FAPI)-Radioligand ...

This narrative review provides an overview of benign FAPI-PET/CT or PET/MRI findings and studies investigating molecular imaging in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11801851/

Discrimination between Inflammatory and Fibrotic Activity in ...

In our study, we analysed three Crohn's disease patients with anastomotic ileo-colonic strictures who underwent both dynamic Ga-68-FAPI-46-PET/ ...

7.

adisinsight.springer.com

adisinsight.springer.com/trials/700388633

Gallium-68-labeled Fibroblast Activation Protein Inhibitor-46 ...

This study is a prospective, case-control study evaluating whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06061874

Study Details | NCT06061874 | Ga68-FAPI-46 PET/CT for ...

The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.

9.

ctv.veeva.com

ctv.veeva.com/study/68ga-fapi-46-pet-ct-for-assessing-small-bowel-fibrostenosis-in-crohns-disease

68Ga-FAPI-46 PET/CT for Assessing Small Bowel ...

This study is a prospective, case-control study evaluating whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohn's ...