No registrations found.
ID
Source
Brief title
Health condition
pancreatic cancer, response assesment, digital PET
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic outcome digital PET/CT
Secondary outcome
Correlation FDG-uptake with Ca 19.9
Background summary
For pancreatic cancer, surgery is the only treatment method that can potentially cure the patient. Currently only 20% of the patients are eligible for a surgical resection with curative intention. A recent development in pancreatic cancer treatment is the use of neo-adjuvant chemotherapy before surgery and this has already shown good clinical results. In these patients, contrast-enhanced Computed Tomography scans (ceCT) of the abdomen are acquired for (re)staging. However, response evaluation with CT scans is unreliable because it is not possible to distinguish between post-treatment fibrosis and malignancies. Recently, a novel digital PET/CT system was introduced in Isala, which provides PET images that are significantly more detailed and accurate as compared to the analog PET systems. Furthermore, the tumour marker Serum Ca 19.9 is widely used for pancreatic adenocarcinoma and has shown its value in the assessment of response to neo-adjuvant therapy. The aim of this study is to evaluate the diagnostic value of digital PET/CT as a staging and restaging imaging modality, as compared with ceCT and Ca 19.9, in patients with resectable or borderline resectable pancreatic cancer, who are treated with neo-adjuvant therapy before surgery.
Study objective
Digital PET improves response evaluation compared to conventional methods
Study design
First FDG-PET/CT scan and second FDG-PET/CT scan
Intervention
Participants will undergo two FDG-PET/CT scans on a digital PET/CT system, before the start of the treatment and after neo-adjuvant chemotherapy treatment
Inclusion criteria
- Histological or cytological confirmed malignant peri-ampullary tumour, resectable or borderline resectable, without evidence of distant metastases
-Inclusion in the PREOPANC-2 study
- Written informed consent
Exclusion criteria
- 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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7243 |
| NTR-old | NTR7442 |
| CCMO | NL64320.075.17 |
| OMON | NL-OMON46552 |