Comparison of FDG and FAPI in Patients With Various Types of Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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.
Disqualifiers
(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.
Trial design
Design model
Single group
Treatments tested in this trial
18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT
Diagnostic testEach subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Experimental: 68Ga-DOTA-FAPI-04Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SUV
Standardized uptake value (SUV) of 18F/ 68Ga-DOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.
Time frame
30 daysSecondary outcomes
1
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.
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov