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Clinical study of radionuclide-labeled FAPI in PET imaging of tumors and non-tumor diseases

Clinical study of radionuclide-labeled FAPI in PET imaging of tumors and non-tumor diseases

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400090727
Enrollment
Unknown
Registered
2024-10-12
Start date
2024-10-15
Completion date
Unknown
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Interventions

Index test:Targeting FAP probes PET/CT imaging

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Criteria for selecting cases Subjects who also meet the conditions of (1) or (2), (3) and (4) were selected for this study. (1) Gender-limited, age 18-80 years old; (2) Patients with suspected or newly diagnosed or treated malignant tumors (supporting evidence includes MRI, CT, tumor markers and pathological reports); (3) Non-tumor diseases such as inflammatory lesions, fibrosis, Ig4-related diseases, atherosclerotic plaque, rheumatoid arthritis and myocardial remodeling; (4) Patients who arrange 18FDG and radionuclide marker FAPI (68Ga-FAPI, 18F-FAPI, FATT, etc.) PET/CT or PET/MR scans at the same time; (5) Patients who can provide informed consent (signed by participants, parents or legal representatives) and agree in accordance with the guidelines of the Clinical Research Ethics Committee. Criteria for selection of healthy subjects: (1) regardless of gender, age of 18-80; (2) no history of major diseases and surgery; (3) normal blood routine, liver and kidney function; (4) subjects who can provide informed consent (signed by participants, parents or legal representatives) and agree in accordance with the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

Exclusion criteria: (1) Those with severe cardiovascular and cerebrovascular diseases; those with liver and kidney insufficiency; (2) Pregnant or breastfeeding; (3) Claustrophobia; (4) Drug and/or alcohol abusers, people with a history of contrast agent or other drug allergies; (5) There are MRI scan contraindications. (5) prior history of severe allergy, or allergy to any active or inactive ingredient of the investigational drug; (6) Insufficient venous access; (7) The researchers judged that it was not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
The number of lesions;Maximum Standard Uptake Value (SUVmax);location of lesion;size of lesion;sensitivity;specificity;positive predictive value;Diagnostic efficacy of cancer;

Countries

China

Contacts

Public ContactPengcheng Ran

Guangdong Provincial Hospital of Chinese Medicine

cmurpc@163.com+86 137 5170 1540

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026