Multi-modality Imaging in the Prediction of Response to Systemic Treatment in Colorectal Cancer

NCT01292681 | Unknown

• 1 other identifier: MICC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Because of metastatic liver cancer of the colon or rectum, patients will be treated with cytotoxic drugs (chemotherapy). In the Radboud University Nijmegen Medical Centre the investigators investigate whether the imaging techniques at an early stage of treatment can predict which patients will have benefited from this treatment. In the study the investigators use two different scanners: a MR (magnetic resonance) scanner and a PET (Positron Emission Tomography) scanner combined with a CT (Computer Tomography) scanner. An MR scanner is a large magnet and looks like a CT scanner which also makes pictures. But instead of using X-rays the recordings are made with magnetic fields. The scan consists of a table on which the patient will lie with the head in a half-dome with a camera. The examination with the MR scan is not painful and not harmful. The PET scan is a type of CT scan that makes (after administration of a radioactive liquid), a scan of (part of) the body. The amount of radioactivity that is used for the study is so small that it will not have an adverse impact on the patient. This research is two times combined with a''normal''CT scan. Using the MR scan, the investigators can research the oxygensupply, the aggressiveness of the tumour and the degree of liver metastases that die from the chemotherapy . The investigators can also, after administration of a MR contrast agent, investigate the blood supply of a tumor through imaging. If you are treated with the chemotherapeutic drug capecitabine the investigators can monitor the intake of this agent in the liver metastases. The PET CT scan tells us more about the metabolism in the liver metastases.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; FDG-PET-CT; MRS,; DCE-MRI; DWI; colorectal cancer with histologically proven distant metastases

Outcome Measures

Primary Outcomes (1)

• Correlation early changes in imaging and treatment outcome

  Correlation early changes in imaging and treatment outcome Week -2-0: PET-CT and MRI Week 0 Start chemotherapy Week 1 PET-CT and MRI Week 9 PET-CT onderzoek

  imaging before start, week 1, week 9

Secondary Outcomes (1)

• Correlation pretreatment imaging values and treatment outcome

  imaging before start, week 1 and week 9

Study Arms (1)

Multi-modality imaging

OTHER

Other: Multi-modality imaging

Interventions

Multi-modality imaging OTHER

Week -2-0 FDG-PET-CT,1H MRS, DCE-MRI, DWI Week 1 1H MRS, DCE-MRI, DWI, 19F MRS, FDG-PET-CT Week 9 FDG-PET-CT

Multi-modality imaging

Eligibility Criteria

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

You may qualify if:

• Histological proven colorectal cancer with histologically proven distant metastases.
• First line fluoropyrimidine-based treatment for liver metastases of colorectal cancer containing fluoropyrimidines.
• Measurable liver metastases of at least 2 cm.
• Age minimal 18 years.
• Written informed consent

You may not qualify if:

• Prior chemotherapy within six months before start of the study.
• Contra-indication for MR and/or PET examinations (e.g. pacemaker, claustrophobia, diabetes mellitus).
• Karnofsky Performance Status \<70.
• Diffuse liver metastases.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• C.J.A. Punt, Md PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

C.J.A. Punt, Md PhD

CONTACT

+31 24 361 03 53; c.punt@onco.umcn.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 9, 2011
• Study Start: August 1, 2009
• Primary Completion: January 1, 2012
• Last Updated: September 8, 2011

Record last verified: 2011-09

Locations

NL (1)