Refractory DermatomyostitisPhase 2FAPI-74NCT06568783
Evaluation of Patients With Refractory Dermatomyositis Using [18F] FAPI-74 PET/MRI Imaging
A Phase 2 study testing [18F]-FAPI-74 in people with Refractory Dermatomyostitis, run by Farshad Moradi at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Dermatomyostitis
- What is being tested?
- [18F]-FAPI-74
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2024to Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected dermatomyositis.
- Patient must be > 18 years old.
- Be willing and able to provide written informed consent for the trial.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Patients With Refractory Dermatomyositis Using [18F]- Fibroblast Activation Protein Inhibitor-74 (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.
- Conditions
- Refractory Dermatomyostitis
- Being tested
- [18F]-FAPI-74
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-FAPI-74Drug
[18F]-FAPI-74 7 mCi ± 20% administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: Drug: [18F]-FAPI-74 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of [18F]-FAPI-74 uptake.
write the outcome title, how it will be measured.
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study startDec 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Refractory DermatomyostitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farshad Moradi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Farshad Moradi, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568783
- Sponsor's protocol ID
- 74917
- Acronym
- FAPI-74
- Status last verified
- Nov 2024
- First submitted
- 21 Aug 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share.
Publications
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.
PubMed 38279381Giesel 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.
PubMed 32591493Kuwert 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.
PubMed 35393350Li 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.
PubMed 37272957Meyer 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.
PubMed 31836685Treutlein 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.
PubMed 36522438Wu 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.
PubMed 34284484Zheng 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.
PubMed 33462628
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Refractory Dermatomyositis Using [18F]- Fibroblast Activation Protein Inhibitor-74 (FAPI-74) PET/MRI Imaging
- ClinicalTrials.gov ID
- NCT06568783
- Acronym / sponsor ID
- FAPI-74 / 74917
- Conditions
- Refractory Dermatomyostitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Farshad MoradiUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| [18F]-FAPI-74 PET/ MRI | Experimental | Drug: [18F]-FAPI-74Participant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with suspected dermatomyositis.
- Patient must be > 18 years old.
- Be willing and able to provide written informed consent for the trial.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]-FAPI-74[18F]-FAPI-74 7 mCi ± 20% administered intravenously. | Drug | [18F]-FAPI-74 PET/ MRI |
Primary outcome
Rate of [18F]-FAPI-74 uptake.
Time frame: up to 1 hour
write the outcome title, how it will be measured.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 38279381Bergmann 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.
- Background: PubMed 32591493Giesel 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.
- Background: PubMed 35393350Kuwert 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.
- Background: PubMed 37272957Li 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.
- Background: PubMed 31836685Meyer 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.
- Background: PubMed 36522438Treutlein 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.
- Background: PubMed 34284484Wu 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.
- Background: PubMed 33462628Zheng 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.
- Individual participant dataSharing planned: No. No plans to share.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]-FAPI-74 in people with Refractory Dermatomyostitis, run by Farshad Moradi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of [18F]-FAPI-74 uptake. (time frame: up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06568783, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.