Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility Study (REMP)

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Drug: Gadobutrol

Study type: Interventional

Funder types: Other

Identifiers

NCT01995240

NL40501.018.12

Details and patient eligibility

About

Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.

Full description

Background of the study:

Novel predictive markers are needed to determine treatment efficacy in pancreatic cancer at an early stage. Preferably, these markers could be determined non-invasively and provide insight into the biology of pancreatic cancer. Several MR techniques can serve for this purpose. However, optimalisation of these techniques is needed and their reproducibility should be assessed.

Objective of the study:

To optimize DCE-MRI, T2* MRI and DWI in pancreatic cancer at 3T and investigate its reproducibility.

Study design:

In the first part of the study, patients with pancreatic cancer will undergo an MR measurement protocol once at 3T, to optimize MR techniques (DCE-MRI, T2* MRI and DWI). In the second part of the study, to assess reproducibility patients will undergo the MR measurement protocol twice within one week before start of any treatment.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with pancreatic tumors, with histological or cytological proof of adenocarcinoma or a high suspicion on CT imaging.
• Any tumor with a size ≥ 1cm
• WHO-performance score 0-2
• Written informed consent

Exclusion criteria

• Any psychological, familial, sociological or geographical condition potentially hampering adequate informed consent or compliance with the study protocol.
• Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or an aneurysm clip in their brain; patients with severe claustrophobia.
• Renal failure (GFR < 30 ml/min) hampering safe administration of Gadolinium containing MR contrast agent.
• For the reproducibility part of the protocol: surgery, radiation and/or chemotherapy foreseen within the timeframe needed for MRI scanning.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Optimization

Experimental group

Description:

For optimization of the protocol patients will undergo one DCE-MRI (Gadobutrol), T2\* MRI and DWI MRI scan.

Treatment:

Drug: Gadobutrol

Reproducibility

Experimental group

Description:

For determination of the reproducibility patients will undergo two DCE-MRI (Gadobutrol), T2\* MRI and DWI MRI scans within one week.

Treatment:

Drug: Gadobutrol