Colorectal CancerNCT01292681
Multi-modality Imaging in the Prediction of Response to Systemic Treatment in Colorectal Cancer
A study testing Multi-modality imaging in people with Colorectal Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Multi-modality imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
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.
Read more
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.
Read the detailed description
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:
- Do pre-treatment characteristics of liver metastases of colorectal cancer as assessed by dynamic contrast enhanced MRI (DCE-MRI), diffusion weighted MRI (DWI), 1H MR spectroscopy (MRS) and FDG-PET predict treatment outcome?
- Do early changes (one week after start of treatment) in DCE-MRI, DWI, 1H MRS and FDG-PET characteristics of liver metastases of colorectal cancer predict treatment outcome?
- Do 19F MRS parameters of fluoropyrimidine metabolism in liver metastases of colorectal cancer predict treatment outcome at an early stage (one week after start of treatment)?
- What is the relative contribution of each above mentioned imaging method to predict treatment outcome of colorectal liver metastases? Design: 60 patients with liver metastases of colorectal cancer treated with fluoropyrimidine-based therapy will participate to the study. Baseline 1H MRS of the liver will be performed in a session at 3 Tesla followed by DCE-MRI and DWI at 1.5 Tesla. FDG-PET will be added to the standard baseline CT scan, using our clinical PET-CT scanner. DCE-MRI, DWI, 1H and 19F MRS as well as FDG-PET of the liver will be repeated one week after start of treatment. Clinical response will be evaluated after three treatment cycles by FDG-PET-CT. We will assess the relative contribution of each imaging method as well as the integrated use of these methods for the identification of predictive biomarkers for response to treatment.
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
- Conditions
- Colorectal Cancer
- Being tested
- Multi-modality imaging
- Keywords
- colorectal cancer, FDG-PET-CT, MRS,, DCE-MRI, DWI, colorectal cancer with histologically proven distant metastases
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modality imagingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Multi-modality imaging | Other | Not described Receives: Other: Multi-modality imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: imaging before start, week 1, week 9
Secondary outcomes (1)
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
Measured: imaging before start, week 1 and week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startAug 2009
- Primary completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C.J.A. Punt, Md PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292681
- Sponsor's protocol ID
- MICC
- Status last verified
- Sep 2011
- First submitted
- 1 Feb 2011
- Last updated
- 8 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modality Imaging in the Prediction of Response to Systemic Treatment in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01292681
- Acronym / sponsor ID
- MICC
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, FDG-PET-CT, MRS,, DCE-MRI, DWI, colorectal cancer with histologically proven distant metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jan 2012 (estimated)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Do pre-treatment characteristics of liver metastases of colorectal cancer as assessed by dynamic contrast enhanced MRI (DCE-MRI), diffusion weighted MRI (DWI), 1H MR spectroscopy (MRS) and FDG-PET predict treatment outcome?
- Do early changes (one week after start of treatment) in DCE-MRI, DWI, 1H MRS and FDG-PET characteristics of liver metastases of colorectal cancer predict treatment outcome?
- Do 19F MRS parameters of fluoropyrimidine metabolism in liver metastases of colorectal cancer predict treatment outcome at an early stage (one week after start of treatment)?
- What is the relative contribution of each above mentioned imaging method to predict treatment outcome of colorectal liver metastases? Design: 60 patients with liver metastases of colorectal cancer treated with fluoropyrimidine-based therapy will participate to the study. Baseline 1H MRS of the liver will be performed in a session at 3 Tesla followed by DCE-MRI and DWI at 1.5 Tesla. FDG-PET will be added to the standard baseline CT scan, using our clinical PET-CT scanner. DCE-MRI, DWI, 1H and 19F MRS as well as FDG-PET of the liver will be repeated one week after start of treatment. Clinical response will be evaluated after three treatment cycles by FDG-PET-CT. We will assess the relative contribution of each imaging method as well as the integrated use of these methods for the identification of predictive biomarkers for response to treatment.
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
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multi-modality imaging | Other | Other: Multi-modality imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modality imagingWeek -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 | Other | Multi-modality imaging |
Primary outcome
Correlation early changes in imaging and treatment outcome
Time frame: imaging before start, week 1, week 9
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
1 secondary outcome
Correlation pretreatment imaging values and treatment outcome
Time frame: imaging before start, week 1 and week 9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C.J.A. Punt, Md PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modality imaging in people with Colorectal Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact C.J.A. Punt, Md PhD (+31 24 361 03 53, c.punt@onco.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation early changes in imaging and treatment outcome (time frame: imaging before start, week 1, week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2011.