Colon CancerNCT04391933
MRI Staging in Colon Cancer
A study testing MRI 3 tesla in people with Colon Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The main purpose of this study is to investigate whether magnetic ressonance imaging (MRI) can be used in treatment planning with assessment of diagnostic accuracy. With the inclusion of 150 patients the study will investigate whether MRI is useful and better than CT scanning in patients with colon tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- MRI 3 tesla
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 31 Dec 2020
- 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
- Diagnosed with colon cancer
- 18 years old or older
- Written and verbally informed consent
Who cannot join
- Pacemakers, implanted medical pumps, and nerve stimulators
- Cochlea implants and cerebral aneurism clips will in some cases be absolute contraindications to MRI examinations.
- Previous treatment with radiation and or chemotherapy
- Serious disease that contraindicates surgical treatment, including severe heart disease
- Any type of cancer other than of the colon (excluding skin cancer, cancer in situ, endometrial cancer, malignant melanoma)
- Any other condition or disease that from the investigator's point of view makes it inappropriate for the patient to participate.
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to investigate whether magnetic ressonance imaging (MRI) can be used in treatment planning with assessment of diagnostic accuracy. With the inclusion of 150 patients the study will investigate whether MRI is useful and better than CT scanning in patients with colon tumors. And also if MRI is useful after neoadjuvant treatment.
Read the detailed description
Colon cancer is a frequent disease in Denmark with over 3200 new cases and about 1350 deaths per year.
CT scanning is currently the national standard method for determining the stage of disease planning for treatment. CT scan can sufficiently distinct between minor and advanced colon tumors. Prevalence of advanced tumors was well over 40% in the CT study from Vejle Hospital in 2013. Sensitivity and specificity of detection of advanced colon tumors in the CT study was approx. 70% and 80%, respectively. A small MRI pilot study showed higher sensitivity and specificity of 89% and 96%, respectively.
MRI scan is currently performed in most patients with rectal cancer, which has resulted in better treatment planning and increased survival. MRI scan of the rectum is documented with higher accuracy than CT scan. There has been reluctance to introduce MRI scan in patients with colon cancer, as the colon has more peristalsis than the rectum, and movement of the bowel can result in image quality reduction in MRI. However, in recent years MRI has become faster and thereby less sensitive to movements.
MRI scanning may in the future help to select the patients who will benefit from neoadjuvant treatment. In addition, with MRI it is possible to perform MRI diffusion measurements of the tumor, which gives an estimate of the tumor's cell density. It will also be possible to investigate whether this changes the MRI diffusion restriction during the neoadjuvant treatment.
This study is prospective and uses state of the art equipment with a 3 tesla MRI unit.
The main purpose of the study is to investigate whether MRI can be used in treatment planning with assessment of diagnostic accuracy. With the inclusion of 150 patients the study investigates whether MRI is useful and better than CT in patients with colon tumors. And also if MRI is useful after neoadjuvant treatment.
- Conditions
- Colon Cancer
- Being tested
- MRI 3 tesla
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI 3 teslaDiagnostic test
MRI of colon cancer. Sensitivity, specificity, positivity predictive values and negative predictive values are calculated form the histopathological surgical specimen. This will be the endpoint for both CT and MRI.
| Study group | Role | What they receive |
|---|---|---|
| MRI colon cancer | Other | MRI scan of patients with colon cancer Receives: Diagnostic Test: MRI 3 tesla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Is MRI usefull in colon cancer patients
Investigate the degree of accuracy in tumor stage compared to the histopathological surgical composition.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Sep 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Sensitivity, specificity, positivity predictive values and negative predictive values are calculated form the histopathological surgical specimen. This will be the endpoint for both CT and MRI.
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren R Rafaelsen, MD, DMSc, Study chair, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391933
- Sponsor's protocol ID
- MR Colon
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Staging in Colon Cancer
- ClinicalTrials.gov ID
- NCT04391933
- Acronym / sponsor ID
- MR Colon
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 May 2020 (actual)
- 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.
The main purpose of this study is to investigate whether magnetic ressonance imaging (MRI) can be used in treatment planning with assessment of diagnostic accuracy. With the inclusion of 150 patients the study will investigate whether MRI is useful and better than CT scanning in patients with colon tumors. And also if MRI is useful after neoadjuvant treatment.
Detailed description
Colon cancer is a frequent disease in Denmark with over 3200 new cases and about 1350 deaths per year.
CT scanning is currently the national standard method for determining the stage of disease planning for treatment. CT scan can sufficiently distinct between minor and advanced colon tumors. Prevalence of advanced tumors was well over 40% in the CT study from Vejle Hospital in 2013. Sensitivity and specificity of detection of advanced colon tumors in the CT study was approx. 70% and 80%, respectively. A small MRI pilot study showed higher sensitivity and specificity of 89% and 96%, respectively.
MRI scan is currently performed in most patients with rectal cancer, which has resulted in better treatment planning and increased survival. MRI scan of the rectum is documented with higher accuracy than CT scan. There has been reluctance to introduce MRI scan in patients with colon cancer, as the colon has more peristalsis than the rectum, and movement of the bowel can result in image quality reduction in MRI. However, in recent years MRI has become faster and thereby less sensitive to movements.
MRI scanning may in the future help to select the patients who will benefit from neoadjuvant treatment. In addition, with MRI it is possible to perform MRI diffusion measurements of the tumor, which gives an estimate of the tumor's cell density. It will also be possible to investigate whether this changes the MRI diffusion restriction during the neoadjuvant treatment.
This study is prospective and uses state of the art equipment with a 3 tesla MRI unit.
The main purpose of the study is to investigate whether MRI can be used in treatment planning with assessment of diagnostic accuracy. With the inclusion of 150 patients the study investigates whether MRI is useful and better than CT in patients with colon tumors. And also if MRI is useful after neoadjuvant treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sensitivity, specificity, positivity predictive values and negative predictive values are calculated form the histopathological surgical specimen. This will be the endpoint for both CT and MRI.
| Arm | Type | Receives |
|---|---|---|
| MRI colon cancer | Other | Diagnostic Test: MRI 3 teslaMRI scan of patients with colon cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with colon cancer
- 18 years old or older
- Written and verbally informed consent
Key exclusion criteria (6 listed)
- Pacemakers, implanted medical pumps, and nerve stimulators
- Cochlea implants and cerebral aneurism clips will in some cases be absolute contraindications to MRI examinations.
- Previous treatment with radiation and or chemotherapy
- Serious disease that contraindicates surgical treatment, including severe heart disease
- Any type of cancer other than of the colon (excluding skin cancer, cancer in situ, endometrial cancer, malignant melanoma)
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 |
|---|---|---|
| MRI 3 teslaMRI of colon cancer. Sensitivity, specificity, positivity predictive values and negative predictive values are calculated form the histopathological surgical specimen. This will be the endpoint for both CT and MRI. | Diagnostic test | MRI colon cancer |
Primary outcome
Is MRI usefull in colon cancer patients
Time frame: 2 years
Investigate the degree of accuracy in tumor stage compared to the histopathological surgical composition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- hospitalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Søren R Rafaelsen, MD, DMSc study chair
Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI 3 tesla in people with Colon Cancer, run by Vejle Hospital at 1 site in Denmark.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 10 Mar 2021. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is MRI usefull in colon cancer patients (time frame: 2 years). 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 10 Mar 2021.