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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04416165
Other study ID # 2019-XJS-1130
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 20, 2019
Est. completion date December 30, 2027

Study information

Verified date June 2023
Source The First Affiliated Hospital of Xiamen University
Contact Hua Wu, PhD
Phone 86 0592-2137166
Email wuhua1025@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date December 30, 2027
Est. primary completion date December 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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. 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.

Study Design


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
China First affiliated hospital of xiamen university XiaMen Fujian

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary SUV Standardized uptake value (SUV) of 18F/ 68Ga-DOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis. 30 days
Secondary Diagnostic efficacy 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. 30 days
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