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

Completed
Conditions
10017991
cancer of the pancreas
pancreatic cancer
Registration Number
NL-OMON46552
Lead Sponsor
Isala Klinieken
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
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

A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Age < 18 years
• Incapacitated adults
• Prisoners
• Pregnancy
• Unable to undergo a FDG-PET/CT scan
• Metastatic or locally advanced (i.e. unresectable) pancreatic cancer
• Ampullary or distal bile duct cancer.
• Prior radiotherapy, chemotherapy, or resection for pancreatic cancer.
• Previous malignancy (excluding non-melanoma skin cancer), unless no evidence of disease and diagnosed more than 2 years before diagnosis of pancreatic cancer.
• Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Diagnostic value (sensitivity, specificity, accuracy) of digital PET/CT for<br /><br>staging and response assessment </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Correlation of staging data and restaging data with tumor marker CA 19.9 serum<br /><br>levels.</p><br>
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