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NCT04499365 Clinical Trial

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

Tumor Clinical Trial

Official title:
68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04499365
Other study ID # FirstAHFujian3
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date August 15, 2020
Est. completion date December 30, 2023

Study information
Verified date September 2020
Source First Affiliated Hospital of Fujian Medical University
Contact Weibing Miao, MD
Phone 86-0591-87981618
Email miaoweibing@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 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 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
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 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.
Diagnostic Test:
• PET/CT scan
PET/CT scan

Locations
Country Name City State
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Standardized uptake value (SUV) Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis. 30 days
Secondary Diagnostic efficacy The sensitivity, specificity and accuracy of 68Ga-DOTA/NOTA-FAPI-04 PET/CT were calculated. 30 days
Secondary Diagnostic efficacy The positive predictive value (PPV), negative predictive value (NPV) 30 days
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