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

21 Participants Needed

Trial Summary

What is the purpose of this trial?

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 imaging for participants with Refractory Dermatomyostitis.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment [18F]-FAPI-74 for dermatomyositis?

The research does not provide direct evidence of the effectiveness of [18F]-FAPI-74 for treating dermatomyositis, but it suggests that similar imaging techniques, like 68Ga-FAPI PET/CT, can effectively identify inflammation in dermatomyositis, which may help in monitoring the disease. ^{1 2 3 4 5}

How does the drug [18F]-FAPI-74 differ from other treatments for dermatomyositis?

[18F]-FAPI-74 is unique because it targets fibroblast activation protein (FAP), which is involved in tissue remodeling and fibrosis, and is used in PET/MRI imaging to detect and potentially treat fibrotic conditions. This approach is different from standard treatments for dermatomyositis, which typically focus on reducing inflammation and immune system activity. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dermatomyositis on 68Ga-FAPI PET/CT in a Patient With Nasopharyngeal Carcinoma. [2023]

2. China pubmed.ncbi.nlm.nih.gov

[The application of (18)F fluorodeoxyglucose-positron emission tomography/computed tomography in the diagnosis and treatment of dermatomyositis]. [2018]

3. China pubmed.ncbi.nlm.nih.gov

18F-FDG PET-CT for the prediction of mortality in patients with dermatomyositis and without malignant tumors: a pilot study. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Detection of inflammatory lesions by f-18 fluorodeoxyglucose positron emission tomography in patients with polymyositis and dermatomyositis. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

(18)F-FDG PET Demonstration of Cancer Recurrence Presenting as Dermatomyositis in a Rare Case of Primary Pleural Lymphoma. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Potential Value of FAPI PET/CT in the Detection and Treatment of Fibrosing Mediastinitis: Preclinical and Pilot Clinical Investigation. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

FAPI-avid nonmalignant PET/CT findings: An expedited systematic review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [18F]FAPI-74 PET for Various Histopathologically Confirmed Cancers and Benign Lesions. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Q.Clear reconstruction for reducing the scanning time for 68 Ga-DOTA-FAPI-04 PET/MR imaging. [2023]

10. Germany pubmed.ncbi.nlm.nih.gov

[68Ga]Ga-FAPI-04 PET/CT on assessing Crohn's disease intestinal lesions. [2023]