2023-507938-24-00RecruitingPhase 3
The effect of [18F]F-FAPI PET-CT on management in patients with potentially resectable biliary tract cancers: prospective multicenter study and cost-effectivity analysis.
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)3 sites in 1 country81 target enrollmentStarted: March 4, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 81
- Locations
- 3
- Primary Endpoint
- sensitivity, specificity, positive predictive value, negative predictive value
Study Overview
Brief Summary
The primary aim of this study is to assess the diagnostic accuracy of [18F]F-FAPI PET-CT in addition to standard preoperative imaging in patients with potentially resectable proximal bile duct cancer (intrahepatic, perihilar and gall bladder cholangiocarcinoma).
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient is scheduled for explorative laparoscopy or laparotomy for suspicion of proximal cholangiocarcinoma (perihilar, intrahepatic and gall bladder cholangiocarcinoma)
- •Tumor is regarded as resectable based on preoperative CT and MRI
- •Patient is 18 years or older and is able to give informed consent
Exclusion Criteria
- •Previous abdominal surgery or chemotherapy
- •Patient had FDG PET-CT in addition to preoperative CT and MRI
- •Contra-indication for performing PET-CT
- •Indication for FDG PET-CT
- •Pregnancy or lactation, for the latter, temporary discontinuation may be considered
- •Known allergic reaction to therapeutic radiopharmaceuticals
- •Inability to lie still on the back for the duration of PET-CT
- •Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m
- •An exception can be made in consultation with the treating physician.
- •Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia)
Outcomes
Primary Outcomes
sensitivity, specificity, positive predictive value, negative predictive value
sensitivity, specificity, positive predictive value, negative predictive value
Secondary Outcomes
- True change and virtual change
- Number of times readers’ conclusions differed
- Cost-effectiveness analysis, budget impact analysis (BIA), sector costs, societal costs, health-related quality of life (HRQoL)
- Number of additional significant findings
- Number of days between date of first imaging (CT/MRI) and starting date of chemotherapy, palliative therapy or surgical resection
- The incidence and severity of AEs and SAEs according to CTCAEv5
- Volume of interest (VOI), time to peak(TTP), K1 and K2, standardize uptake value (SUV), tumor-to-background ratio (TBR)
Investigators
Dr. Maarten Thomeer
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Study Sites (3)
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