Contrast-enhanced Diffusion-weighted MRI to Detect Liver Metastases in Patients With Pancreatic Cancer

Pancreatic Neoplasms Clinical Trial

— DIA-PANC  

Official title:

Diagnostic Accuracy of Contrast-enhanced Diffusion-weighted MRI for Liver Metastases of Pancreatic Cancer: Towards Adequate Staging and Follow-up of Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03469726
• Other study ID #: NL60473.091.17
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2017
• Est. completion date: January 1, 2023

Study information

• Verified date: October 2020
• Source: Radboud University
• Contact: Geke Litjens, MD
• Phone: +31243668392
• Email: g.litjens[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Given the dismal prognosis of pancreatic cancer, detecting liver metastases early can avoid inappropriate therapy with the associated substantial risks, long-term hospital admissions and high costs, but without survival benefit. The current standard of diagnostic workup with contrast-enhanced CT (CECT) has a poor sensitivity (38-76%) for the detection of liver metastases. As more sophisticated and expensive treatment options emerge, better staging of pancreatic cancer is needed to avoid unnecessary procedures and select the most appropriate treatment strategy. New imaging modalities are available, but their value in staging of pancreatic cancer has not been evaluated yet. Therefore prospective imaging studies are necessary. The main aim of this study is to determine the diagnostic accuracy of contrast-enhanced diffusion-weighted MRI (CE-DW-MRI) in the detection of liver metastases in patients with pancreatic cancer compared to a reference standard of histopathology and follow up imaging. The study is an international, multicenter prospective cohort study (inclusion of patients until 138 patients with liver metastases are included, with a total maximum of 465 patients). Patients with pancreatic cancer will undergo additional CE-DW-MRI within two weeks from the CECT. CECT and CE-DW-MRI will be read independently by two radiologists. Suspected liver lesions on CECT and/or CE-DW-MRI will be biopsied to obtain histopathology as reference standard. For liver lesions without histopathologic proof of metastases a paired follow-up CECT and CE-DW-MRI serve as a composite reference standard. Pancreatic resection will be pursued in patients without proven liver or distant metastases. Patients with locally advanced or metastatic disease will be offered palliative treatment. Follow up CECT and CE-DW-MRI will be performed in all patients at 3, 6, and 12 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 465
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Neoplasm Metastasis
• Pancreatic Neoplasms

Intervention

Diagnostic Test:
• Contrast-enhanced Diffusion-weighted MRI
An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values

Locations

Country	Name	City	State
Greece	Konstantopouleio general hospital	Athens
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Radboudumc	Nijmegen	Gelderland
Spain	Hospital Universitario Ramón y Cajal	Madrid
Switzerland	Inselspital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Cancer Society

Countries where clinical trial is conducted

Greece,  Netherlands,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	One year survival	Survival rate after 1 year of follow-up	Maximum 1 year
Other	Median survival	Median survival time	Maximum 1 year
Other	Disease free survival	Time without (local) recurrence of cancer in patients that underwent resection	Maximum 1 year
Other	Progression free survival	Time without progression of cancer	Maximum 1 year
Primary	Diagnostic accuracy of CE-DW-MRI	Sensitivity and Specificity of CE-DW-MRI for the detection of liver metastases in patients with pancreatic cancer compared to CECT.	Baseline
Secondary	Detection of metastasis on CE-DW-MRI in follow-up (3, 6 and 12 months after baseline)	Detection of metastasis with CE-DW-MRI, compared to CECT, in follow-up (3, 6 and 12 months after baseline) of patients with pancreatic cancer, after or during therapy	3, 6 and 12 months
Secondary	Assess local resectability	Sensitivity and specificity for CT and MRI to assess local resectability for all patients that underwent surgery	Baseline