68Ga-FAPI PET/CT in Patients With Various Types of Cancer

NCT04499365 · tracked via the Priya Life Science China tracker

Sponsor

First Affiliated Hospital of Fujian Medical University

Phase

Phase EARLY_PHASE1

Started

2020-08-15

Last updated

2026-07-21

Condition(s) studied

TumorPositron-Emission TomographyMetastasis

Investigational drug(s) / intervention(s)

68Ga-DOTA/NOTA-FAPI-04PET/CT scan

68Ga-DOTA/NOTA-FAPI-04: Each patient receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT scan within specified time.

PET/CT scan: PET/CT scan

Study summary

To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Eligibility

Sex

ALL

Min age

18 Years

Max age

90 Years

Healthy volunteers

Inclusion Criteria: * (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: * (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcome measure(s)

Standardized uptake value (SUV) — 30 days
Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	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 NCT04499365 on ClinicalTrials.gov ↗ ← All trials in China