Comparison of FDG and FAPI in Patients With Various Types of Cancer

Not Applicable

Recruiting

• Conditions: Metastasis; Tumor, Solid; Positron-Emission Tomography
• Interventions: Diagnostic Test: 18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT

• Registration Number: NCT04416165
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

To evaluate the potential usefulness of 68Ga-DOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.

Detailed Description

Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Study Timeline

• Study Start: 2019-10-20
• Study First Submitted: 2020-06-01
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-04
• Status Verified: 2023-06
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08
• Primary Completion: 2027-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• (i) adult patients (aged 18 years or order); (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report); (iii) patients who had scheduled both 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT scans; (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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: 68Ga-DOTA-FAPI-04	18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT	Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.

Primary Outcome Measures

Name	Time	Method
SUV	30 days	Standardized uptake value (SUV) of 18F/ 68Ga-DOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary Outcome Measures

Name	Time	Method
Diagnostic efficacy	30 days	The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Trial Locations

Locations (1)

First affiliated hospital of xiamen university; 🇨🇳 XiaMen, Fujian, China