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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.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507938-24-00
Enrollment
81
Registered
2024-03-04
Start date
2024-11-29
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiocarcinoma

Brief summary

sensitivity, specificity, positive predictive value, negative predictive value

Detailed description

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)

Interventions

DRUGGlucaGen®
DRUGHypoKit met 1 mg poeder en oplosmiddel voor oplossing voor injectie
DRUGScopolamine butylbromide Kalceks 20 mg/ml oplossing voor injectie

Sponsors

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
sensitivity, specificity, positive predictive value, negative predictive value

Secondary

MeasureTime frame
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)

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026