Hyperthyroidism, AutoimmunePhase 1/2NCT07400224
Clinical Application of Al18F-NOTA-FAPI-04 PET/CT or PET/MRI Imaging in Malignant Tumor,Cardiovascular or Immune Disease
A Phase 1/2 study testing Al18F-NOTA-FAPI PET/CT(or PET/MRI) in people with Hyperthyroidism, Autoimmune and Cardiovascular Abnormalities, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-FAPI PET imaging in patients with malignant tumor,cardiovascular or immune disease. And evaluates the potential of Al18F-NOTA-FAPI PET imaging in Clinical treatment strategy guidance. Read more about this study
- Who is it for?
- Ages 18 to 88 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthyroidism, Autoimmune, Cardiovascular Abnormalities, Malignant Tumor
- What is being tested?
- Al18F-NOTA-FAPI PET/CT(or PET/MRI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2022to 31 Dec 2028
- Phase
- Phase 1/2
- 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 to 88 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a. Age 18 years old or above, gender not restricted. b. Have undergone a health check-up within the last 3 months (at least completed chest X-ray / chest CT and abdominal B-ultrasound and other examinations), and no major diseases were found.
Who cannot join
- As this study involves certain radiation exposure, patients who have had frequent radiation exposure due to clinical needs (those who have undergone a CT or PET/CT examination once within 3 months or 1 month respectively) are not included 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.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Peking Union Medical College Hospital, +86 010-69154702, huoli@pumch.cn
About this study
This prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-FAPI PET imaging in patients with malignant tumor,cardiovascular or immune disease. And evaluates the potential of Al18F-NOTA-FAPI PET imaging in Clinical treatment strategy guidance.
Read the detailed description
FAP is expected to become an important indicator for predicting tumor prognosis, and also a new target for individualized treatment of various diseases such as tumors, rheumatoid arthritis, myocardial infarction, and thyroid-associated ophthalmopathy. The biological distribution of FAP in healthy adults is not yet clear. It is planned to obtain the normal PET/CT (or PET/MRI) images of healthy subjects after they use this tracer, in order to establish a benchmark for future application in patients.
- Being tested
- Al18F-NOTA-FAPI PET/CT(or PET/MRI)
- Medical subject headings
- Graves Disease, Cardiovascular Abnormalities, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al18F-NOTA-FAPI PET/CT(or PET/MRI)Other
Participants will receive an intravenous injection of Al18F-NOTA-FAPI, prepared on-site and measured by qualified personnel using a dose calibrator, with readings and time recorded. The radiopharmaceutical will be slowly administered through a three-way stopcock, followed by a flush with 5 mL of normal saline. The recommended dose is approximately 4.81 MBq/kg (0.13 mCi/kg) body weight, with variations depending on drug yield and clinical scheduling. PET/CT(or PET/MRI) imaging are planned 45-90 minutes after administration, with adjustments based on drug yield and equipment availability.
| Study group | Role | What they receive |
|---|---|---|
| Al18F-NOTA-FAPI PET/CT(PET/MRI) | Experimental | Evaluation of dosimetry, safety, diagnostic accuracy, and clinical treatment strategy guidance ability of Al18F-NOTA-FAPI PET/CT(or PET/MRI) in patients with malignant tumor,cardiovascular or immune disease. Receives: Other: Al18F-NOTA-FAPI PET/CT(or PET/MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Al18F-NOTA-FAPI
Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Measured: From radiotracer injection to 24 hours post-injection.
Diagnostic accuracy of Al18F-NOTA-FAPI PET/CT(PET/MRI) for cardiovascular or immune disease.
SUVmax 、SUVmean and T2 value（MRI）of the heart and the eye muscles will be measured. Two nuclear medicine physicians will independently review the images, and a third physician will adjudicate in case of disagreement to reach a final diagnosis. Surgical pathology results or Long term follow up findings will serve as the reference standard to determine the sensitivity and specificity .
Measured: Through study completion, 1-1.5 years .
Secondary outcomes (2)
SUVmax of normal organs
The biodistribution of Al18F-NOTA-FAPI will be assessed in the following organs: pituitary gland, parotid glands, thyroid glands, lungs, blood pool, liver, spleen, pancreas (including the head and uncinate process), gallbladder, stomach, small intestine, kidneys, and adrenal glands. The SUVmax values for these organs will be measured and documented.
Measured: From study completion to 6 months after completion.
Absorbed dose of target organs
Absorbed dose of target organs were calculated using HERMES software.
Measured: From study completion to 6 months after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start10 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hyperthyroidism, AutoimmuneStudies 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
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400224
- Sponsor's protocol ID
- JS-3423
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang X, Gan L, Shi X, Wu M, Li E, Zhang Y, Hao Z, Huang Z, Xing H, Liu X, Huo L. Integrated 18F-NOTA-FAPI-04 PET/MRI for quantitative assessment of disease activity in thyroid-associated ophthalmopathy. Eur J Nucl Med Mol Imaging. 2026 Aug 28. doi: 10.1007/s00259-026-08157-x. Online ahead of print.
PubMed 42660999
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Al18F-NOTA-FAPI-04 PET/CT or PET/MRI Imaging in Malignant Tumor,Cardiovascular or Immune Disease
- ClinicalTrials.gov ID
- NCT07400224
- Acronym / sponsor ID
- JS-3423
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Feb 2026 (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 prospective, single-center study investigates the biodistribution, dosimetry, safety, diagnostic performance of Al18F-NOTA-FAPI PET imaging in patients with malignant tumor,cardiovascular or immune disease. And evaluates the potential of Al18F-NOTA-FAPI PET imaging in Clinical treatment strategy guidance.
Detailed description
FAP is expected to become an important indicator for predicting tumor prognosis, and also a new target for individualized treatment of various diseases such as tumors, rheumatoid arthritis, myocardial infarction, and thyroid-associated ophthalmopathy. The biological distribution of FAP in healthy adults is not yet clear. It is planned to obtain the normal PET/CT (or PET/MRI) images of healthy subjects after they use this tracer, in order to establish a benchmark for future application in patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Al18F-NOTA-FAPI PET/CT(PET/MRI) | Experimental | Other: Al18F-NOTA-FAPI PET/CT(or PET/MRI)Evaluation of dosimetry, safety, diagnostic accuracy, and clinical treatment strategy guidance ability of Al18F-NOTA-FAPI PET/CT(or PET/MRI) in patients with malignant tumor,cardiovascular or immune disease. |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a. Age 18 years old or above, gender not restricted. b. Have undergone a health check-up within the last 3 months (at least completed chest X-ray / chest CT and abdominal B-ultrasound and other examinations), and no major diseases were found.
Key exclusion criteria (1 listed)
- As this study involves certain radiation exposure, patients who have had frequent radiation exposure due to clinical needs (those who have undergone a CT or PET/CT examination once within 3 months or 1 month respectively) are not included 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 |
|---|---|---|
| Al18F-NOTA-FAPI PET/CT(or PET/MRI)Participants will receive an intravenous injection of Al18F-NOTA-FAPI, prepared on-site and measured by qualified personnel using a dose calibrator, with readings and time recorded. The radiopharmaceutical will be slowly administered through a three-way stopcock, followed by a flush with 5 mL of normal saline. The recommended dose is approximately 4.81 MBq/kg (0.13 mCi/kg) body weight, with variations depending on drug yield and clinical scheduling. PET/CT(or PET/MRI) imaging are planned 45-90 minutes after administration, with adjustments based on drug yield and equipment availability. | Other | Al18F-NOTA-FAPI PET/CT(PET/MRI) |
Primary outcome
Safety of Al18F-NOTA-FAPI
Time frame: From radiotracer injection to 24 hours post-injection.
Adverse effects were recorded according to CTCAE (version 5.0) after radiotracer injection and PET scan.
Diagnostic accuracy of Al18F-NOTA-FAPI PET/CT(PET/MRI) for cardiovascular or immune disease.
Time frame: Through study completion, 1-1.5 years .
SUVmax 、SUVmean and T2 value（MRI）of the heart and the eye muscles will be measured. Two nuclear medicine physicians will independently review the images, and a third physician will adjudicate in case of disagreement to reach a final diagnosis. Surgical pathology results or Long term follow up findings will serve as the reference standard to determine the sensitivity and specificity .
2 secondary outcomes
SUVmax of normal organs
Time frame: From study completion to 6 months after completion.
Absorbed dose of target organs
Time frame: From study completion to 6 months after completion
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 10 Feb 2026.
- Derived from this study: PubMed 42660999Yang X, Gan L, Shi X, Wu M, Li E, Zhang Y, Hao Z, Huang Z, Xing H, Liu X, Huo L. Integrated 18F-NOTA-FAPI-04 PET/MRI for quantitative assessment of disease activity in thyroid-associated ophthalmopathy. Eur J Nucl Med Mol Imaging. 2026 Aug 28. doi: 10.1007/s00259-026-08157-x. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Al18F-NOTA-FAPI PET/CT(or PET/MRI) in people with Hyperthyroidism, Autoimmune and Cardiovascular Abnormalities, 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 1 inclusion and 1 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 10 Feb 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Li Huo, MD (+86 18612672038, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Al18F-NOTA-FAPI (time frame: From radiotracer injection to 24 hours post-injection.). The study lists 2 primary outcomes in all. 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 NCT07400224, which also lists 1 linked publication.
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 10 Feb 2026.