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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.

Phase 1
Conditions
Cholangiocarcinoma
Therapeutic area: Diseases [C] - Neoplasms [C04]
Registration Number
CTIS2023-507938-24-00
Lead Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
96
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 m2. 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)

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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