RecruitingPhase 1Phase 2NCT07400224

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


Sponsor

Peking Union Medical College Hospital

Enrollment

600 participants

Start Date

May 10, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 88 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating how well a PET/CT or PET/MRI scan using a new imaging tracer (Al18F-NOTA-FAPI-04 — which targets a protein called FAP found in cancer tissue and areas of inflammation) can detect tumors, cardiovascular disease, and immune conditions. Researchers are comparing it to standard CT and ultrasound results to see if it provides additional useful information. **You may be eligible if...** - You are 18 or older - You have had a routine health check within the past 3 months (at minimum a chest X-ray or CT and abdominal ultrasound) with no major diseases detected, and are considered healthy **You may NOT be eligible if...** - You have had frequent radiation exposure recently (CT/PET scan within the past 1–3 months, depending on type) - You are pregnant or breastfeeding - You have conditions that make radiation exposure inadvisable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERAl18F-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.


Locations(1)

Peking Union Medical College Hospital

Beijing, China

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NCT07400224


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