SAPHO SyndromeEarly Phase 1NCT04596462
Characterizing SAPHO With 68Ga-FAPI PET/CT
A Early Phase 1 study testing 68Ga-FAPI in people with SAPHO Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SAPHO Syndrome
- What is being tested?
- 68Ga-FAPI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2020to Jul 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected or confirmed untreated SAPHO patients;
- 18F-FDG PET/CT within two weeks;
- signed written consent.
Who cannot join
- pregnancy;
- breastfeeding;
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking union medical college hospital
Beijing, Dongcheng, 100010
Peipei Wang, MD, 18511395988, wpp199411@163.com
Guozhu Hou, MD, 15611145656, 15611145656@163.com
About this study
Official title: Characterizing Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) With 68Ga-FAPI PET/CT
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of SAPHO than 18F-FDG PET/CT.
Read the detailed description
Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a spectrum of heterogeneous diseases characterized by osteoarticular and dermatological manifestations. Inflammatory osteitis with hyperostosis is the central feature of the syndrome, typically affecting multiple areas and possibly progressing to irreversible osteoarticular damage. Owing to the relapsing-remitting disease course, the goal of management is to improve clinical symptoms and prevent disease progression. Therefore, it's meaningful to seek appropriate methods to evaluate current osteroarticular lesions. 68Ga-FAPI that targets fibroblast activation protein (FAP) is introduced in tumor imaging. However, FAP was also shown to be expressed in rheumatoid arthritis, bone lesions with acute to chronic inflammation, fibrosis and ischemic heart tissue after myocardial infarction, thus the investigators speculate that it is possible for SAPHO to be imaged with 68Ga-FAPI. The aim of this study is to evaluate the performance of 68Ga-FAPI PET/CT in SAPHO and to compare it with the performance of 18F-FDG PET/CT.
- Conditions
- SAPHO Syndrome
- Being tested
- 68Ga-FAPI
- Medical subject headings
- Acquired Hyperostosis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPIDrug
Also called 68Ga-fibroblast activating protein inhibitors
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of SAPHO by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI PET/CT | Experimental | Inject 68Ga-FAPI and then perform PET/CT scan. Receives: Drug: 68Ga-FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and Specificity of 68Ga-FAPI PET/CT for SAPHO in comparison with 18F-FDG PET/CT
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Metabolic parameters
Total Lesion Glycolysis (TLG) of SAPHO lesions are measured on 68Ga-FAPI PET/CT.
Measured: through study completion, an average of 1 year
FAPI expression and SUV
Correlation between FAPI expression and SUV in PET
Measured: through study completion, an average of 1 year
Disease burden assessement
Correlation between Total Lesion Glycolysis (TLG) of bone lesions assessed on 68Ga-FAPI PET/CT and clinical parameters for SAPHO
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start8 Jun 2020
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SAPHO SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongli Jing, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596462
- Sponsor's protocol ID
- PekingUMCHFAPISAPHO
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis (SAPHO) With 68Ga-FAPI PET/CT
- ClinicalTrials.gov ID
- NCT04596462
- Acronym / sponsor ID
- PekingUMCHFAPISAPHO
- Conditions
- SAPHO Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 22 Oct 2020 (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.
68Ga-FAPI has been developed as a tumor-targeting agent as fibroblast activation protein is overexpressed in cancer-associated fibroblasts and some inflammation. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment and follow-up of SAPHO than 18F-FDG PET/CT.
Detailed description
Synovitis, acne, pustulosis, hyperostosis, and osteitis (SAPHO) syndrome is a spectrum of heterogeneous diseases characterized by osteoarticular and dermatological manifestations. Inflammatory osteitis with hyperostosis is the central feature of the syndrome, typically affecting multiple areas and possibly progressing to irreversible osteoarticular damage. Owing to the relapsing-remitting disease course, the goal of management is to improve clinical symptoms and prevent disease progression. Therefore, it's meaningful to seek appropriate methods to evaluate current osteroarticular lesions. 68Ga-FAPI that targets fibroblast activation protein (FAP) is introduced in tumor imaging. However, FAP was also shown to be expressed in rheumatoid arthritis, bone lesions with acute to chronic inflammation, fibrosis and ischemic heart tissue after myocardial infarction, thus the investigators speculate that it is possible for SAPHO to be imaged with 68Ga-FAPI. The aim of this study is to evaluate the performance of 68Ga-FAPI PET/CT in SAPHO and to compare it with the performance of 18F-FDG PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI PET/CT | Experimental | Drug: 68Ga-FAPIInject 68Ga-FAPI and then perform PET/CT scan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suspected or confirmed untreated SAPHO patients;
- 18F-FDG PET/CT within two weeks;
- signed written consent.
Key exclusion criteria (4 listed)
- pregnancy;
- breastfeeding;
- known allergy against FAPI
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
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 |
|---|---|---|
| 68Ga-FAPIAlso: 68Ga-fibroblast activating protein inhibitorsIntravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of SAPHO by PET/CT. | Drug | 68Ga-FAPI PET/CT |
Primary outcome
Diagnostic value
Time frame: through study completion, an average of 1 year
Sensitivity and Specificity of 68Ga-FAPI PET/CT for SAPHO in comparison with 18F-FDG PET/CT
3 secondary outcomes
Metabolic parameters
Time frame: through study completion, an average of 1 year
FAPI expression and SUV
Time frame: through study completion, an average of 1 year
Disease burden assessement
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hongli Jing, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-FAPI in people with SAPHO Syndrome, run by Peking Union Medical College Hospital at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 23 Oct 2020. 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 China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peipei Wang, MD (18511395988, wpp199411@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2020.