An interventional study of Multi-modality imaging in Colorectal Cancer, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-08.
Sponsored by Radboud University Medical Center · Not applicable and Interventional
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.
Colorectal cancer is a frequently occurring cancer and about half of the patients develop distant metastases to the liver. Only a subset of patients respond to systemic treatment, which is potentially toxic and expensive. Therefore, predictive markers are needed to determine treatment efficacy at an early stage. Preferably, they should provide insight into the biology of colorectal cancer liver metastasis. In the past it has been shown that several biomarkers as assessed with PET, MRI and MRS can serve as predictive markers. Response to systemic therapy depends on several factors: delivery of the drug by the tumor vascular system; cellular uptake, retention and metabolism; intrinsic sensitivity to a specific drug. The relative contribution of these factors to response will be different for different drugs. Since systemic treatment of colorectal cancer involves a combination of drugs, predictive markers should be sensitive to a range of these factors. In this project we propose the integrated analysis of noninvasive functional and molecular in vivo imaging methods in order to predict the response to treatment in patients with liver metastases of colorectal cancer. Tumor vascularity can be assessed by dynamic contrast enhanced magnetic resonance imaging (DCE-MRI). The fluoropyrimidines FU and capecitabine - which are part of standard treatment regimens - contain a fluorine atom which can be measured by fluorine-19 MR spectroscopy (19F MRS). The intracellular uptake and metabolism of drugs is an energy-consuming process. 18F-Fluoro-2-deoxyglucose positron emission tomography (FDG-PET) provides information on glucose uptake and hexokinase activity. Tumor characterization in terms of grade and aggressiveness may give a relevant approximation to the intrinsic sensitivity of a tumor to a drug. With 1H MRS the total amount of choline (tCho), a precursor of cell membranes, can be measured. Tumor cellularity and extracellular matrix composition can be assessed with diffusion weighted MRI (DWI).
The aim of this study is to obtain data on the biology data of colorectal cancer liver metastasis, namely tumor vascularization (DCE-MRI), tumor cellularity (DWI), tumor (choline) metabolism (1H MRS) and tumor glucose metabolism (FDG-PET). These data will be correlated with the clinical outcome of patients and with drug uptake and metabolism (19F MRS). We will study the relative contribution of each imaging method to predict the outcome of patients with colorectal cancer at an early stage.
Research questions:
Relevance of this study: Since the response of a tumor to systemic drugs may be highly variable between patients, a method that predicts the sensitivity of a tumor to treatment at an early stage would enable individualization of therapy and consequently would protect patients against the toxic effects of ineffective treatment. Preferably, those predictive markers should also give us further insight into the biology of colorectal cancer. For this reason we propose to study a combination of in vivo noninvasive imaging methods which allow the monitoring of relevant biomarkers
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 60 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
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Exclusion Criteria:
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
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
Time frame: imaging before start, week 1, week 9
Correlation pretreatment imaging values and treatment outcome
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
Time frame: imaging before start, week 1 and week 9
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