Thyroid Eye DiseaseNCT06359795
Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease
A study testing 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT in people with Thyroid Eye Disease, run by Peking University Third Hospital at 1 site in China.
Trial summary
FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Thyroid Eye Disease
- What is being tested?
- 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2023to 31 Dec 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Patients diagnosed with TED;
- Complete understanding and voluntary participation in this study, with the signing of an informed consent form.
Who cannot join
- Severe liver or kidney dysfunction;
- Inability to maintain a supine position for 5 minutes to cooperate with the examination;
- Suffering from claustrophobia or other psychiatric disorders;
- Patients planning pregnancy or in the prenatal or lactation period;
- Other conditions deemed unsuitable for participation in the trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dept. of Nuclear Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hui Li, Dr., 86-13121136769, huilee1990@163.com
Lingge Suo, Dr., 86-010-82264935, suolingge_1019@126.com
About this study
FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED.
Read the detailed description
Subjects with TED underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT for activity assessment within a 10-day period. On 18F-AlF-FAPI PET/CT, uptake in the extraocular muscles was quantified using SUV metrics and target-to-background ratio. On 99mTc-DTPA SPECT/CT, uptake in the extraocular muscles was semi-quantified using the uptake ratio. Activity of TED was determined through comprehensive clinical data. The correlation between SUV metrics and activity status was calculated to explore the value of 18F-AlF-FAPI PET/CT in assessing TED activity. The diagnostic accuracy of 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT in assessing TED activity was compared. Additionally, the correlation of changes in SUV metrics and therapy response will be calculated to explore the value of 18F-AlF-FAPI PET/CT in therapy response assessment of TED.
- Conditions
- Thyroid Eye Disease
- Being tested
- 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT
- Medical subject headings
- Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CTDiagnostic test
Patients underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT scans within 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Patients with TED will be recruited in the study.
Interventions:
Diagnostic Test: 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT. Receives: Diagnostic Test: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
The accuracy of 18F-AlF-FAPI PET/CT in assessing the activity of TED.
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
The value to predict therapy response
The changes of SUV metrics on 18F-AlF-FAPI PET/CT to predict therapy response
Measured: through study completion, an average of 12 months
Diagnostic accuracy comparison
Comparing the diagnostic accuracy in assessing the activity of TED activity between 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT.
Measured: through study completion, an average of 6 months
FAPI expression and SUV metrics
Correlation between SUV metrics on PET and FAPI expression in patients with surgery.
Measured: through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 Dec 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid Eye DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Li, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359795
- Sponsor's protocol ID
- FAPI-TED
- Status last verified
- Apr 2024
- First submitted
- 7 Apr 2024
- Last updated
- 11 Apr 2024
- 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 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Value of 18F-AlF-FAPI PET/CT in Assessing the Activity of Thyroid Eye Disease
- ClinicalTrials.gov ID
- NCT06359795
- Acronym / sponsor ID
- FAPI-TED
- Conditions
- Thyroid Eye Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Apr 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.
FAPI PET has been developed as a promising approach for the evaluation of fibroinflammatory, such as in inflammatory bowel disease. This prospective study aims to explore the value of 18F-AlF-FAPI PET/CT in assessing the activity of Thyroid Eye Disease (TED) and investigate whether FAPI PET/CT may be superior to 99mTc-DTPA SPECT/CT for the diagnosis, therapy response assessment, and follow-up of TED.
Detailed description
Subjects with TED underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT for activity assessment within a 10-day period. On 18F-AlF-FAPI PET/CT, uptake in the extraocular muscles was quantified using SUV metrics and target-to-background ratio. On 99mTc-DTPA SPECT/CT, uptake in the extraocular muscles was semi-quantified using the uptake ratio. Activity of TED was determined through comprehensive clinical data. The correlation between SUV metrics and activity status was calculated to explore the value of 18F-AlF-FAPI PET/CT in assessing TED activity. The diagnostic accuracy of 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT in assessing TED activity was compared. Additionally, the correlation of changes in SUV metrics and therapy response will be calculated to explore the value of 18F-AlF-FAPI PET/CT in therapy response assessment of TED.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Diagnostic Test: 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CTPatients with TED will be recruited in the study. Interventions: Diagnostic Test: 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years;
- Patients diagnosed with TED;
- Complete understanding and voluntary participation in this study, with the signing of an informed consent form.
Key exclusion criteria (5 listed)
- Severe liver or kidney dysfunction;
- Inability to maintain a supine position for 5 minutes to cooperate with the examination;
- Suffering from claustrophobia or other psychiatric disorders;
- Patients planning pregnancy or in the prenatal or lactation period;
- Other conditions deemed unsuitable for participation in the trial by the investigator.
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-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CTPatients underwent 18F-AlF-FAPI PET/CT and 99mTc-DTPA SPECT/CT scans within 10 days. | Diagnostic test | Experimental arm |
Primary outcome
Diagnostic accuracy
Time frame: through study completion, an average of 6 months
The accuracy of 18F-AlF-FAPI PET/CT in assessing the activity of TED.
3 secondary outcomes
The value to predict therapy response
Time frame: through study completion, an average of 12 months
Diagnostic accuracy comparison
Time frame: through study completion, an average of 6 months
FAPI expression and SUV metrics
Time frame: through study completion, an average of 12 months
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 11 Apr 2024.
- 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.
Hui Li, Dr. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-AlF-FAPI PET/CT, 99mTc-DTPA SPECT/CT in people with Thyroid Eye Disease, run by Peking University Third 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 5 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: looking for participants now, as of the sponsor's last update on 11 Apr 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 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.
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?
Contact Hui Li, Dr. (86-13121136769, huilee1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: through study completion, an average of 6 months). 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 11 Apr 2024.