Multi-modality Imaging in the Prediction of Response to Systemic Treatment in Colorectal Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Other: Multi-modality imaging |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Multi-modality Imaging in the Prediction of Response to Systemic Treatment in Colorectal Cancer |
- Correlation early changes in imaging and treatment outcome [ Time Frame: imaging before start, week 1, week 9 ] [ Designated as safety issue: No ]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
- Correlation pretreatment imaging values and treatment outcome [ Time Frame: imaging before start, week 1 and week 9 ] [ Designated as safety issue: No ]Correlation pretreatment imaging values 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
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2009 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Multi-modality imaging |
Other: Multi-modality imaging
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
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations| Contact: C.J.A. Punt, Md PhD | +31 24 361 03 53 | c.punt@onco.umcn.nl |
| Netherlands | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Gelderland, Netherlands, 6500 HB | |
| Principal Investigator: | C.J.A. Punt, Md PhD | Radboud University |
More Information
No publications provided
| Responsible Party: | Radboud University |
| ClinicalTrials.gov Identifier: | NCT01292681 History of Changes |
| Other Study ID Numbers: | MICC |
| Study First Received: | February 1, 2011 |
| Last Updated: | September 7, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
colorectal cancer FDG-PET-CT MRS, |
DCE-MRI DWI colorectal cancer with histologically proven distant metastases |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013