FAPI PET/CT in Various FAP-Related Disease Patients
1 other identifier
observational
500
1 country
1
Brief Summary
To evaluate the potential usefulness of 68Ga/18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various FAP-related disease patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 12, 2024
CompletedFirst Posted
Study publicly available on registry
November 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
February 11, 2025
February 1, 2025
5.6 years
November 12, 2024
February 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standardized uptake value (SUV)
Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.
30 days
Secondary Outcomes (1)
Diagnostic efficacy
30 days
Interventions
68Ga-DOTA/NOTA-FAPI-04 Each subject receive a single intravenous injection of 68Ga/18F-FAPI, and undergo PET/CT imaging within the specificed time.
Eligibility 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 FAPI 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.
You may qualify if:
- (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 FAPI 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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
November 12, 2024
First Posted
November 14, 2024
Study Start
March 1, 2022
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
February 11, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share