Added value of digital PET/CT in (re)staging patients with pancreatic cancer
- Conditions
- 10017991cancer of the pancreaspancreatic 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
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.
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
Name Time Method <p>Diagnostic value (sensitivity, specificity, accuracy) of digital PET/CT for<br /><br>staging and response assessment </p><br>
- Secondary Outcome Measures
Name Time Method <p>Correlation of staging data and restaging data with tumor marker CA 19.9 serum<br /><br>levels.</p><br>