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Added value of digital PET/CT in (re)staging patients with pancreatic cancer

Added value of digital PET/CT in (re)staging patients with pancreatic cancer - (Re)stadiering of digital PET in pancreatic cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46552
Enrollment
40
Registered
2018-03-19
Start date
2018-09-13
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

cancer of the pancreas pancreatic cancer

Interventions

None listed

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Histological or cytological confirmed malignant peri-ampullary tumour, resectable or borderline resectable, without evidence of distant metastases. • Inclusion in the Preopanc-2 study and randomized for neo-adjuvant chemotherapy • Written informed consent There is an additional inclusion criterion for the acquisition of the second FDG-PET/CT scan: only patients that are treated with at least 4 cycles, and a maximum of 8 cycles of neo-adjuvant chemotherapy will be referred for this FDG-PET/CT scan.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Age

Design outcomes

Primary

MeasureTime frame
Diagnostic value (sensitivity, specificity, accuracy) of digital PET/CT for staging and response assessment

Secondary

MeasureTime frame
Correlation of staging data and restaging data with tumor marker CA 19.9 serum levels.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)