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

Pancreatic Cancer Clinical Trial

— REMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995240
• Other study ID #: NL40501.018.12
• Status: Completed
• Phase: N/A
• First received: November 21, 2013
• Last updated: March 17, 2017
• Start date: April 2013
• Est. completion date: February 2017

Study information

• Verified date: March 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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