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NCT Number: NCT07400224

Clinical Application of Al18F-NOTA-FAPI-04 PET/CT or PET/MRI Imaging in Malignant Tumor,Cardiovascular or Immune Disease

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.

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Key information

Conditions

Hyperthyroidism, Autoimmune Autoimmune Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Hyperthyroidism Immune System Diseases Malignant Tumor Neoplasms Orbital Diseases Thyroid Diseases

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, China

Location status: Recruiting

Location contact

Peking Union Medical College Hospital

CONTACT

[email protected]

+86 010-69154702

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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 .

Secondary outcomes

  1. SUVmax of normal organs

    Time frame: From study completion to 6 months after completion.

    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.

  2. Absorbed dose of target organs

    Time frame: From study completion to 6 months after completion

    Absorbed dose of target organs were calculated using HERMES software.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Huo, MD

CONTACT

[email protected]

+86 18612672038

Xueqian Yang, MS

CONTACT

[email protected]

+86 18801349606

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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