Functional Magnetic Resonance Imaging Of Pancreatic Cancer: A Feasibility And Reproducibility Study

Study Overview

Functional Magnetic Resonance Imaging of Pancreatic Cancer: a Feasibility and Reproducibility 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.

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.

Pancreatic Cancer

DRUG: Gadobutrol

NL40501.018.12

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-11-21	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-03-17
First Submitted that Met QC Criteria 2013-11-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-03-20
First Posted (ACTUAL) 2013-11-26	Results First Posted N/A	Last Verified 2017-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Optimization For optimization of the protocol patients will undergo one DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scan.	DRUG: Gadobutrol 0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
EXPERIMENTAL: Reproducibility For determination of the reproducibility patients will undergo two DCE-MRI (Gadobutrol), T2* MRI and DWI MRI scans within one week.	DRUG: Gadobutrol 0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Optimization

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

DRUG: Gadobutrol

0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush

EXPERIMENTAL: Reproducibility

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

DRUG: Gadobutrol

0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush

Primary Outcome Measures	Measure Description	Time Frame
Reproducibility of DCE, T2* and DWI MRI in pancreatic cancer.	To assess reproducibility, 15 patients will undergo the MR measurement protocol twice within one week before start of any treatment. Reproducibility of; DWI: mean ADC of the whole tumor. DCE: mean Ktrans of the whole tumor. T2*: average value of the whole tumor.	Within 1 week

Secondary Outcome Measures	Measure Description	Time Frame
Compare in vivo measurements of tumor vascularity, hypoxia and stroma using DCE-MRI, T2* MRI and DWI with immunohistochemically determined markers of vascularity, hypoxia and stroma in pancreatic tumor tissue	In those patients for whom tumor tissue is available which has not been treated with radiation or chemotherapy, DCE-MRI, T2* MRI and DWI will be compared with immunohistochemical markers of vascularity, hypoxia and stroma (e.g. CD-31, HIF1-alfa, CA9, GLUT1, PAI-1, VEGF, anti-SMA).	Within 1 week
To explore the relation between in vivo measurements of tumor vascularity, hypoxia and stroma using DCE-MRI, T2* MRI and DWI and treatment outcome.		1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: H WM van Laarhoven, M.D., Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications

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General Publications

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Clinical Trial Record