ClinicalTrials.gov record NCT06568783

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Evaluation of Patients With Refractory Dermatomyositis Using [18F]- Fibroblast Activation Protein Inhibitor-74 (FAPI-74) PET/MRI Imaging

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age18 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2 interventional study uses [18F]-FAPI-74 PET/MRI in people with refractory dermatomyositis. Participants receive an IV injection of the tracer, wait about 45–60 minutes, then undergo an MRI from head to legs followed by a PET scan to measure tracer uptake.

What it is studying. The study is testing the use of the PET tracer [18F]-FAPI-74 together with MRI to measure how much tracer is taken up in the bodies of people with refractory dermatomyositis. The main measurement is the rate of [18F]-FAPI-74 uptake on PET/MRI.

What the researchers hope to learn. To measure the rate of [18F]-FAPI-74 uptake on PET/MRI (primary outcome) and to describe imaging patterns of tracer distribution in refractory dermatomyositis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: [18F]-FAPI-74

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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

Exclusion criteria

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After giving written informed consent and undergoing screening for MRI safety and pregnancy, participants receive an intravenous injection of [18F]-FAPI-74 (7 mCi ±20%). About 45–60 minutes after the injection they have an MRI scan from head to legs followed by a static PET scan over the same area. The imaging requires lying flat for roughly 30 minutes while scans are taken; the study measures tracer uptake during the imaging session.

How the study is structured. Phase 2, single-group (single-arm), open-label interventional imaging study. Each participant receives a single intravenous dose of [18F]-FAPI-74 (about 7 mCi ±20%), waits roughly 45–60 minutes, then has a whole-body MRI followed by a static PET emission scan over the same area. There is no masking.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says recruitment has not started. When is it expected to open, and can I register interest now?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: December 2024 (estimated)
Primary completion: October 2027 (estimated)
Study completion: October 2028 (estimated)
Target enrollment: 21 participants (estimated)
Last updated on registry: Nov 29, 2024
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Farshad Moradi

Participating sites (1)

Stanford University
Stanford, California, 94304 · United States

Terms used on this page · explanations by MedicalUpdates.ai

PET: A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
single-arm: All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
MRI: A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
Refractory: A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Contraindication: A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
principal investigator: The doctor or scientist responsible for running the study at a site or overall.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials