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

NCT06568783 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 74917
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Dermatomyostitis

Outcome Measures

Primary Outcomes (1)

• Rate of [18F]-FAPI-74 uptake.

  write the outcome title, how it will be measured.

  up to 1 hour

Study Arms (1)

[18F]-FAPI-74 PET/ MRI

EXPERIMENTAL

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.

Drug: [18F]-FAPI-74

Interventions

[18F]-FAPI-74 DRUG

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

[18F]-FAPI-74 PET/ MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Farshad Moradi: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

Related Publications (8)

• Bergmann C, Distler JHW, Treutlein C, Tascilar K, Muller AT, Atzinger A, Matei AE, Knitza J, Gyorfi AH, Luck A, Dees C, Soare A, Ramming A, Schonau V, Distler O, Prante O, Ritt P, Gotz TI, Kohner M, Cordes M, Bauerle T, Kuwert T, Schett G, Schmidkonz C. 68Ga-FAPI-04 PET-CT for molecular assessment of fibroblast activation and risk evaluation in systemic sclerosis-associated interstitial lung disease: a single-centre, pilot study. Lancet Rheumatol. 2021 Mar;3(3):e185-e194. doi: 10.1016/S2665-9913(20)30421-5. Epub 2021 Jan 25.

  PMID: 38279381 BACKGROUND

• Giesel FL, Adeberg S, Syed M, Lindner T, Jimenez-Franco LD, Mavriopoulou E, Staudinger F, Tonndorf-Martini E, Regnery S, Rieken S, El Shafie R, Rohrich M, Flechsig P, Kluge A, Altmann A, Debus J, Haberkorn U, Kratochwil C. FAPI-74 PET/CT Using Either 18F-AlF or Cold-Kit 68Ga Labeling: Biodistribution, Radiation Dosimetry, and Tumor Delineation in Lung Cancer Patients. J Nucl Med. 2021 Feb;62(2):201-207. doi: 10.2967/jnumed.120.245084. Epub 2020 Jun 26.

  PMID: 32591493 BACKGROUND

• Kuwert T, Schmidkonz C, Prante O, Schett G, Ramming A. FAPI PET Opens a New Window to Understanding Immune-Mediated Inflammatory Diseases. J Nucl Med. 2022 Aug;63(8):1136-1137. doi: 10.2967/jnumed.122.263922. Epub 2022 Apr 7. No abstract available.

  PMID: 35393350 BACKGROUND

• Li J, Wei W, Xu W, Wu W, Liu J, Ye S. [68Ga]Ga-FAPI-04 and [18F]FDG PET/ CT in a patient with MDA5 dermatomyositis. Eur J Nucl Med Mol Imaging. 2023 Oct;50(12):3790-3791. doi: 10.1007/s00259-023-06291-4. Epub 2023 Jun 5. No abstract available.

  PMID: 37272957 BACKGROUND

• Meyer C, Dahlbom M, Lindner T, Vauclin S, Mona C, Slavik R, Czernin J, Haberkorn U, Calais J. Radiation Dosimetry and Biodistribution of 68Ga-FAPI-46 PET Imaging in Cancer Patients. J Nucl Med. 2020 Aug;61(8):1171-1177. doi: 10.2967/jnumed.119.236786. Epub 2019 Dec 13.

  PMID: 31836685 BACKGROUND

• Treutlein C, Distler JHW, Tascilar K, Fakhouri SC, Gyorfi AH, Atzinger A, Matei AE, Dees C, Buttner-Herold M, Kuwert T, Prante O, Bauerle T, Uder M, Schett G, Schmidkonz C, Bergmann C. Assessment of myocardial fibrosis in patients with systemic sclerosis using [68Ga]Ga-FAPI-04-PET-CT. Eur J Nucl Med Mol Imaging. 2023 May;50(6):1629-1635. doi: 10.1007/s00259-022-06081-4. Epub 2022 Dec 16.

  PMID: 36522438 BACKGROUND

• Wu J, Qiu L, Wang Y, Zhang C. Dermatomyositis on 68Ga-FAPI PET/CT in a Patient With Nasopharyngeal Carcinoma. Clin Nucl Med. 2022 Feb 1;47(2):149-150. doi: 10.1097/RLU.0000000000003809.

  PMID: 34284484 BACKGROUND

• Zheng J, Chen H, Lin K, Yao S, Miao W. [68Ga]Ga-FAPI and [18F]FDG PET/CT images in a patient with juvenile polymyositis. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):2051-2052. doi: 10.1007/s00259-020-05185-z. Epub 2021 Jan 18. No abstract available.

  PMID: 33462628 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: This is a prospective, single-center, single-arm study enrolling 21 adult participants to evaluate \[18F\]-FAPI-74 PET/ MRI for assessment of muscle and soft tissue involvement in Dermatomyositis.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)