Rectal CancerNCT01745874
Diagnostic Value of Whole-Body MRI for Rectal Cancer Preoperative Staging
An observational study of Rectal Cancer, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Rectal Cancer
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2012to Oct 2013
- Phase
- Observational
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a rectal cancer
Who may be able to join
- rectal cancer T3 N+ or T3 or T4
Who cannot join
- renal failure
- allergy to iodinated contrast medium
- contraindication to MRI
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Lausanne Hospitals
Lausanne, Canton of Vaud, 1011
Milena Cerny, Resident, 0041795561102, milena.cerny@chuv.ch
Sabine Schmidt Kobbe, MER, 0041213144444, sabine.schmidt@chuv.ch
About this study
Official title: Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment
The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer.
Read the detailed description
Rectal cancer is the second cause of mortality after lung cancer in industrialized countries and represent 28% of colorectal carcinomas. Despite major improvements in diagnosis and treatment made those last years,mortality and morbidity remains high, because of high prevalence of metastasis and local recurrence. A accurate initial staging is of paramount importance for an appropriate treatment (neoadjuvant chemiotherapy and radiotherapy, surgery).
Actually, there is no international consensus concerning imaging for the staging of rectal cancer and modalities used are variable from one center to another.
WB-MRI represented a attractive and promising technique for the staging of rectal cancer, free of ionizing radiation .
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Whole-body MRI, FDG-PET-CT, preoperative staging
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment
We will compare for each body region the findings of the whole-body MRI to the FDG-PET-CT considered as the gold-standard and measure sensibility/specificity and diagnostic accuracy of the whole-body MRI for distant lesions of rectal cancer.
Measured: baseline and 1 week before surgery
Secondary outcomes (1)
Tumoral regression after neoadjuvant treatment
Evaluate the tumoral regression after neoadjuvant treatment on the MRI by the measurement of the ADC (attenuation diffusion coefficient) increase and compare the results to the measure of the SUV (standard uptake value) decrease on the FDG-PET-CT.
Measured: baseline and six weeks after the end of the neoadjuvant treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milena Cerny, University of Lausanne Hospitals
- Investigators
- Milena Cerny, Principal investigator, University of Lausanne HospitalsSabine Schmidt Kobbe, Dr., Principal investigator, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745874
- Sponsor's protocol ID
- 247/12
- Status last verified
- Dec 2012
- First submitted
- 2 Dec 2012
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Whole-Body MRI Compared to FDG-PET-CT for Rectal Cancer Preoperative Staging, Before and After Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT01745874
- Acronym / sponsor ID
- 247/12
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Whole-body MRI, FDG-PET-CT, preoperative staging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 10 Dec 2012 (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.
The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer.
Detailed description
Rectal cancer is the second cause of mortality after lung cancer in industrialized countries and represent 28% of colorectal carcinomas. Despite major improvements in diagnosis and treatment made those last years,mortality and morbidity remains high, because of high prevalence of metastasis and local recurrence. A accurate initial staging is of paramount importance for an appropriate treatment (neoadjuvant chemiotherapy and radiotherapy, surgery).
Actually, there is no international consensus concerning imaging for the staging of rectal cancer and modalities used are variable from one center to another.
WB-MRI represented a attractive and promising technique for the staging of rectal cancer, free of ionizing radiation .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a rectal cancer
Key inclusion criteria (1 listed)
- rectal cancer T3 N+ or T3 or T4
Key exclusion criteria (3 listed)
- renal failure
- allergy to iodinated contrast medium
- contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment
Time frame: baseline and 1 week before surgery
We will compare for each body region the findings of the whole-body MRI to the FDG-PET-CT considered as the gold-standard and measure sensibility/specificity and diagnostic accuracy of the whole-body MRI for distant lesions of rectal cancer.
1 secondary outcome
Tumoral regression after neoadjuvant treatment
Time frame: baseline and six weeks after the end of the neoadjuvant treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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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.
Milena Cerny principal investigator
University of Lausanne Hospitals
Sabine Schmidt Kobbe, Dr. principal investigator
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 1 inclusion and 3 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 10 Dec 2012. 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 Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment (time frame: baseline and 1 week before surgery). 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 Dec 2012.