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NCT Number: NCT06568783

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

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.

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Key information

Conditions

Refractory Dermatomyostitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University

Stanford, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[18F]-FAPI-74

Drug

[18F]-FAPI-74 7 mCi ± 20% administered intravenously.

Primary outcomes

  1. Rate of [18F]-FAPI-74 uptake.

    Time frame: up to 1 hour

    write the outcome title, how it will be measured.

Sponsors and collaborators

Lead sponsor

Farshad Moradi

Other

Registry information

Official study title

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

Acronym: FAPI-74

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 23, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.