FAPI-74 PET/MRI for Dermatomyositis

(FAPI-74 Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Farshad Moradi

Disqualifiers: Pregnancy, MRI contraindication, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method for individuals with dermatomyositis, a condition that causes skin rashes and muscle weakness and often resists treatment. Researchers aim to determine if a PET/MRI scan using [18F]-FAPI-74, a radiotracer, can enhance understanding of the disease. Participants will receive an injection and then undergo scans to capture detailed images from head to toe. The trial seeks individuals who suspect they have dermatomyositis and can comfortably lie still for about 30 minutes during the scan. As a Phase 2 trial, the research focuses on evaluating the effectiveness of the imaging method in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that [18F]-FAPI-74 is likely to be safe for humans?

Research shows that [18F]-FAPI-74, used in PET scans, is generally well-tolerated. Earlier studies used this PET tracer to examine lung changes in patients, and the results suggest it is safe. Reports from these studies have not indicated any major side effects related to [18F]-FAPI-74.

Since this trial is in Phase 2, researchers have already tested the treatment for safety in humans. It is considered safe enough to proceed with further testing. However, ongoing studies must provide more information to fully understand any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dermatomyositis?

Researchers are excited about [18F]-FAPI-74 for dermatomyositis because it offers a novel imaging approach that could improve disease assessment. Unlike current treatments that primarily focus on managing symptoms through medications like corticosteroids and immunosuppressants, [18F]-FAPI-74 is used in PET/MRI scans to potentially provide detailed insights into the inflammation and muscle involvement associated with the condition. This imaging agent targets fibroblast activation protein, which is highly expressed in inflamed tissues, making it a promising tool for more precise diagnosis and monitoring of dermatomyositis.

What evidence suggests that [18F]-FAPI-74 might be an effective treatment for dermatomyositis?

Research has shown that a substance called [18F]-FAPI-74 might be useful in imaging conditions like dermatomyositis. Although it hasn't been proven to treat dermatomyositis, a case report found that it could highlight active disease areas, such as lung problems, in patients. Studies on similar conditions suggest that [18F]-FAPI-74 can detect cells involved in disease activity. Early results also indicate that it helps identify changes related to lung scarring in other diseases. These findings suggest that [18F]-FAPI-74 could effectively visualize dermatomyositis. Participants in this trial will receive an [18F]-FAPI-74 injection followed by a PET/MRI scan to assess its effectiveness in imaging dermatomyositis. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with refractory dermatomyositis, a condition where standard treatments haven't worked. Participants must meet certain health criteria to be included, but specific inclusion and exclusion details are not provided in the given information.

Inclusion Criteria

I might have dermatomyositis.

Be willing and able to provide written informed consent for the trial

I am over 18 years old.

Exclusion Criteria

I cannot have an MRI or lie flat for 30 minutes.

I am not pregnant nor planning to become pregnant soon.

Any serious medical condition that in the opinion of principal investigator could pose significant risk of harm or injury to the patient if they participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive [18F]-FAPI-74 injection followed by MRI and PET scans

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]-FAPI-74

Trial Overview [18F]-FAPI-74 PET/MRI imaging is being tested in this study. It's a single-center, single-arm trial which means all participants will receive the same intervention without comparison to another group or treatment.

How Is the Trial Designed?

Group I: [18F]-FAPI-74 PET/ MRI Experimental Treatment 1 Intervention

Participant receive \[18F\]-FAPI-74 injection and approximately 45-60 minutes later receive a MRI scan from vertex to legs, followed by a static PET emission scan over the same area.

Who Is Running the Clinical Trial?

Farshad Moradi

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

In a study involving 31 patients with various confirmed cancers, [18F]FAPI-74 PET demonstrated significantly higher uptake in primary cancer lesions compared to nonmalignant lesions, indicating its potential for better cancer detection.

[18F]FAPI-74 PET outperformed [18F]FDG PET in detecting primary and metastatic lesions, suggesting it could be a more effective diagnostic tool for cancer staging and treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [18F]FAPI-74 PET for Various Histopathologically Confirmed Cancers and Benign Lesions. Watabe, T., Naka, S., Tatsumi, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06568783

Evaluation of Patients With Refractory Dermatomyositis ... This study proposes the use of a PET isotope, [18F]-Fibroblast Activation Protein Inhibitor-74, for a prospective single-center, single-arm study using MRI ...

2. withpower.com withpower.com/trial/phase-2-dermatomyositis-9-2024-e6ff5

FAPI-74 PET/MRI for Dermatomyositis · Info for Participants The research does not provide direct evidence of the effectiveness of [18F]-FAPI-74 for treating dermatomyositis, but it suggests that similar imaging ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11019096/

FAPi PET/CT for assessment and visualisation of active ... We found a case report involving a female dermatomyositis patient highlighted elevated FAPi activity correlating with pulmonary fibrosis.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05641896

NCT05641896 | Study of [18F]FAPI-74 PET in Patients With ... Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11043111/

Initial results with [18F]FAPI-74 PET/CT in idiopathic ... The initial results confirm our assumption that [18F]FAPI-74 offers a viable non-invasive assessment method for pulmonary fibrotic changes in patients with IPF.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06568783

Evaluation of Patients With Refractory Dermatomyositis ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/590736

Evaluation of Patients With Refractory Dermatomyositis ... This study proposes the use of a PET isotope, \[18F\]-Fibroblast Activation Protein Inhibitor-74, for a prospective single-center, single-arm study using MRI ...

8. bcan.org bcan.org/clinicaltrials/18f-fibroblast-activation-protein-inhibitor-18ffapi-74-pet-imaging-for-cancer-detection/

18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) ... If [18F]-FAPi PET scan shows no tumor(s), scans will not be repeated. If the participant's cancer progresses within 2 years, scans may be repeated. Follow-up ...