Evaluation of Patients With Refractory Dermatomyositis Using [18F] FAPI-74 PET/MRI Imaging

Farshad Moradi

Status and phase: Not yet enrolling; Phase 2

Conditions: Refractory Dermatomyostitis

Treatments: Drug: [18F]-FAPI-74

Study type: Interventional

Funder types: Other

Identifiers

NCT06568783

74917

Details and patient eligibility

About

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.

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with suspected dermatomyositis.
2. Patient must be > 18 years old.
3. Be willing and able to provide written informed consent for the trial.

Exclusion criteria

1. Women who are pregnant or potentially pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.
2. Contraindication to MRI or inability to lie flat for 30 min
3. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

[18F]-FAPI-74 PET/ MRI

Experimental group

Description:

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.

Treatment:

Drug: [18F]-FAPI-74