68Ga-FAPI PET/CT in Patients With Various Types of Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-DOTA/NOTA-FAPI-04, PET/CT scan.
- Who it may be relevant to
- Registry conditions: Tumor, Positron-Emission Tomography, Metastasis. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer
Overview
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.
Detailed 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.
Interventions
- 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
Primary outcome measures
- Standardized uptake value (SUV) [Time frame: 30 days]
Secondary outcome measures (2)
- Diagnostic efficacy [Time frame: 30 days]
- Diagnostic efficacy [Time frame: 30 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- The First Affiliated Hospital of Fujian Medical University — Fuzhou
Publications
- Zheng S, Lin J, Zhu Y, Chen Y, Zhang J, Chen X, Miao W. 68Ga-FAPI Versus 18F-FDG PET/CT in Evaluating Newly Diagnosed Breast Cancer Patients: A Head-to-Head Comparative Study. Clin Nucl Med. 2023 Mar 1;48(3):e104-e109. doi: 10.1097/RLU.0000000000004523. Epub 2023 Jan 10. PMID 36723892
- Chen Y, Zheng S, Zhang J, Yao S, Miao W. 68Ga-DOTA-FAPI-04 PET/CT imaging in radioiodine-refractory differentiated thyroid cancer (RR-DTC) patients. Ann Nucl Med. 2022 Jul;36(7):610-622. doi: 10.1007/s12149-022-01742-8. Epub 2022 May 12. PMID 35551610
- Zheng S, Lin R, Chen S, Zheng J, Lin Z, Zhang Y, Xue Q, Chen Y, Zhang J, Lin K, You X, Yao S, Miao W. Characterization of the benign lesions with increased 68Ga-FAPI-04 uptake in PET/CT. Ann Nucl Med. 2021 Dec;35(12):1312-1320. doi: 10.1007/s12149-021-01673-w. Epub 2021 Aug 23. PMID 34424505
Identifiers
NCT: NCT04499365 · FirstAHFujian3