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

NCT01995240 | Completed

• 1 other identifier: NL40501.018.12
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; MRI; reproducibility; optimalization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  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

Study Arms (2)

Optimization

EXPERIMENTAL

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

Drug: Gadobutrol

Reproducibility

EXPERIMENTAL

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

Drug: Gadobutrol

Interventions

Gadobutrol DRUG

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

Also known as: Gadovist

Optimization; Reproducibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

gadobutrol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• H WM van Laarhoven, M.D., Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 26, 2013
• Study Start: April 1, 2013
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 20, 2017

Record last verified: 2017-03

Locations

NL (1)