Diagnostic accuracy of contrast-enhanced diffusion-weighted MRI for liver metastases of<br>pancreatic cancer: towards adequate staging and follow-up of pancreatic cancer

Recruiting

Conditions: Liver metastases
10027476

Registration Number: NL-OMON49213

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 465

Inclusion Criteria

- 18 years and older
- clinical suspicion of pancreatic cancer
- written (signed and dated) informed consent

Exclusion Criteria

- Previous treatment for pancreatic cancer (e.g. chemotherapy, radiotherapy,
surgery, ablation therapy)
- Concomitant malignancies, except for adequately treated basocellular
carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with
prior malignancies must be disease-free for at least 5 years
- Contra-indications to undergo CT (due to e.g. extreme claustrophobia,
untreatable contrast allergy, renal function impairment)
- Contra-indications to undergo MRI (due to e.g. claustrophobia, untreatable
contrast allergy, or not MRI compatible medical devices)
- Insufficient command of the Dutch language to be able to understand the
patient information or fill in the questionnaires
- Pregnancy

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Sensitivity and specificity of CECT and CE-DW-MRI for the detection of liver<br /><br>metastasis.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- sensitivity and specificity for CT and MRI to assess local resectability for<br /><br>all patients that underwent surgery<br /><br>- inter-observer variability for detection of liver metastases<br /><br>- median and one year survival<br /><br>- disease free survival<br /><br>- difference in overall survival in patients with few and many (>5) liver<br /><br>metastases<br /><br>- effect on patient management of early detection of liver metastases<br /><br>- cost effective analysis and budget impact analysis<br /><br>- to evaluate the effect of disease progression and metastatic burden in<br /><br>relation to tumor markers (Ca19.9 and CEA)</p><br>