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Clinical Trials in China / NCT07400224
Recruiting Phase 1/2

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

NCT07400224 · tracked via the Priya Life Science China tracker
Sponsor
Peking Union Medical College Hospital
Phase
Phase 1/2
Started
2022-05-10
Last updated
2026-02-10

Condition(s) studied

Hyperthyroidism, AutoimmuneCardiovascular AbnormalitiesMalignant Tumor

Investigational drug(s) / intervention(s)

Al18F-NOTA-FAPI PET/CT(or PET/MRI)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
88 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Safety of Al18F-NOTA-FAPI — 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. — 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 .

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07400224 on ClinicalTrials.gov ↗ ← All trials in China