Clinical trial NCT06568783: Evaluation of Patients With Refractory Dermatomyositis Using [18F] FAPI-74 PET/MRI Imaging
Official title: Evaluation of Patients With Refractory Dermatomyositis Using [18F]- Fibroblast Activation Protein Inhibitor-74 (FAPI-74) PET/MRI Imaging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Refractory Dermatomyostitis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of [18F]-FAPI-74 uptake.
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.