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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49213
Enrollment
465
Registered
2019-08-14
Start date
2017-12-22
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Liver metastases

Interventions

Pancreatic cancer

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of CECT and CE-DW-MRI for the detection of liver metastasis.

Secondary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)