Rectal CancerNCT03463616
MRI Imaging or CT Abdomen as Standard Work-up Before Treatment Planning for Rectal Cancer?
An observational study of Rectal Cancer and Liver Metastases, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Rectal cancer is a common diagnosis. The prognosis after treatment has improved over the last decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical technique (TME) and, in certain cases, due to adjuvant therapy after surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer, Liver Metastases
- What is being tested?
- CT abdomen and MRI abdomen
- Type of treatment
- Surgery or procedure
- How many people
- 320 participants
- Where
- 1 siteSweden
- Study dates
- 15 Mar 2018to 31 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients in the Swedish Colo- Rectal Cancer Registry (SCRCR) and treated for rectal cancer at Sahlgrenska University Hospital and Norra Älvsborg Hospital 2013-2015.
Who may be able to join
- All patients in the Swedish Colo- Rectal Cancer Registry (SCRCR) and treated for rectal cancer at Sahlgrenska University Hospital and Norra Älvsborg Hospital 2013-2015.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Rectal cancer is a common diagnosis. The prognosis after treatment has improved over the last decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical technique (TME) and, in certain cases, due to adjuvant therapy after surgery. For some 15-20 years, treatment of metastasis has changed; liver- and lung metastasis in certain situations are surgically removed, or in the liver, treated with ablation (radio-frequency). During the same period the possibilities for chemotherapy of metastatic disease have improved, with new drugs and more drug regimens.
These changes in treatment pathways have required changes in how patients with newly diagnosed rectal cancer are "worked up" pre-treatment. Starting in the early 2000s magnetic resonance imaging of the pelvic area has developed and is today mandatory to be able to adequately stage the tumour and plan for the multi-modal treatment before and after surgery.
Read more
In many hospitals the set-up is a combination of computed tomography of the abdomen and chest and to this a MRI of the pelvic organs is added, whereas others have adopted MRI also for the abdominal part, thus having an MRI of the liver for the diagnosis of liver metastasis initially, before surgery. For the chest organs, CT is still normative.
MRI has a higher sensitivity and specificity to detect liver metastasis, compared with CT. In order to plan the liver surgery/ablations, most liver surgeons rely on MRI for detailed information about the position of the metastasis and the relation to large vessels.
The aim of this study is to examine the possible differences in percentage of patients requiring further radiology examinations after basic set-up comparing the routine of initial MRI of abdomen (and pelvic organs) with the routine of initial CT of the abdomen (and MRI of the pelvic organs). Further included is an analysis of the rate of liver metastasis using the two different routines, and finally outcome over 12 months in terms of liver treatment for metastasis.
Read the detailed description
Background:
Rectal cancer is a common diagnosis in both men and women, more commonly occurring in men (60%) than women (40%). In Sweden some 2000 cases are diagnosed each year. The prognosis after treatment has improved over the last decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical technique (TME) and, in certain cases, due to adjuvant therapy after surgery.
For some 15-20 years, treatment of metastasis has changed; liver- and lung metastasis in certain situations are surgically removed, or in the liver, treated with ablation (radio frequency). During the same period the possibilities for chemotherapy of metastatic disease have improved, with new drugs and more drug regimens.
These changes in treatment pathways have required changes in how patients with newly diagnosed rectal cancer are "worked up" pre-treatment. Starting in the early 2000s magnetic resonance imaging of the pelvic area has developed and is today mandatory to be able to adequately stage the tumour and plan for the multi-modal treatment before and after surgery.
In many hospitals the set-up is a combination of computed tomography of the abdomen and chest and to this a MRI of the pelvic organs is added, whereas others have adopted MRI also for the abdominal part, thus having an MRI of the liver for the diagnosis of liver metastasis initially, before surgery. For the chest organs, CT is still normative.
MRI has a higher sensitivity and specificity to detect liver metastasis, compared with CT. In order to plan the liver surgery/ablations, most liver surgeons rely on MRI for detailed information about the position of the metastasis and the relation to large vessels.
The objective of the study is to examine:
The possible differences in percentage of patients requiring further radiology examinations after basic set-up comparing the routine of initial MRI of abdomen (and pelvic organs) with the routine of initial CT of the abdomen (and MRI of the pelvic organs). Further included is an analysis of the rate of liver metastasis using the two different routines, and finally outcome over 12 months in terms of liver treatment for metastasis.
Hypothesis:
Primary:
- Patients who underwent initial abdominal MRI had a significantly lower need for additional radiology examinations compared with those who underwent initial CT abdomen.
Secondary:
- A higher proportion of patients who underwent initial abdominal MRI underwent liver treatment aiming for cure at 12 months.
- Abdominal MRI as initial examination resulted in a higher proportion of detected liver metastasis.
- Cost effectiveness analysis will show that initial abdominal MRI of the abdominal organs is cost-effective.
Design:
A retrospective study using clinical details such as date for diagnosis, clinical tumour stage, type of surgical treatment and date, pathology tumour stage, local recurrence and survival at 36 months from the Swedish ColoRectal Cancer Registry for patients with rectal cancer treated at Sahlgrenska University Hospital and Norra Älvsborg Hospital during the years collecting patients backwards from 2015-12-31 until sufficient number is reached (see below "Sample size").
Data will be collected in the radiology patient documentation at the two hospitals using the original radiology report for the index examinations as well as type and number of additional radiology examinations and the reports for those.
For patients with liver metastases in the original radiology report at the index work-up and in cases with indeterminate initial results, the original radiology examinations will be re-evaluated by one or if possible two radiologists.
Data from the clinical patient records on treatment plan (index treatment) and time and type of treatment for liver metastasis.
No direct contact with patients is planned, and only data already collected (see above) will be used.
Methodology:
Through Regional Cancer Center West (RCC Väst) appropriate data from to Swedish ColoRectal Cancer Register will be collected, consisting of age, time for diagnosis, time for multidisciplinary conference, time for oncological treatment, time for surgery, cTNM as well as pTNM, performed treatment/s within 12 months, recurrence/s and survival (3 years).
Data to be collected from radiology reports include presence of liver metastasis, number of liver metastasis, additional radiology examinations after index work-up - type and number as well as findings of liver metastasis. Additional findings of distant metastases to retro peritoneal lymph-nodes and to peritoneum will also be recorded.
Data from re-evaluation of examinations for all patients diagnosed with liver metastases such as number of metastases, number of small metastases (<10mm), metastases to retro peritoneal lymph-nodes and to peritoneum.
Data to be collected from hospital records for all patients include time line for different aspects of treatment including multidisciplinary conference (and decision), oncological treatment and liver surgery until 12 months from diagnosis.
- Conditions
- Rectal Cancer, Liver Metastases
- Being tested
- CT abdomen, MRI abdomen
- Keywords
- Rectal Cancer, Liver Metastases, CT abdomen, MRI Liver
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT abdomenRadiation
CT scan of abdomen for metastasis staging of rectal cancer
MRI abdomenRadiation
MRI of abdomen for metastasis staging of rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| CT abdomen | Patients who had a CT abdomen as primary work-up before treatment planning for rectal cancer. Receives: Radiation: CT abdomen | |
| MRI Abdomen | Patients who had a MRI abdomen as primary work-up before treatment planning for rectal cancer. Receives: Radiation: MRI abdomen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who needed additional radiology examination/s before treatment planning after routine MRI of abdominal organs compared with routine CT of abdominal organs.
Measured: 3 months
Secondary outcomes (5)
Comparison of percentage of patients treated with liver surgery/ablation within 12 months between the two groups.
Measured: 12 months
Comparison of the percentage of patients who were diagnosed with liver metastasis, between the two groups.
Measured: 3 years
Cost effectiveness analysis of routine MRI of abdominal organs compared with routine CT of abdominal organs.
Total cost differences between MRI and CT-scan as primary routine work-up measured in USD.
Measured: 3 years
Overall survival after 3 years
Measured: 3 years
Disease free survival after 3 years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start15 Mar 2018
- Primary completion31 Mar 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattias Prytz, Sahlgrenska University Hospital
- Investigators
- Mattias Prytz, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463616
- Sponsor's protocol ID
- MRvsCT
- Status last verified
- Apr 2021
- First submitted
- 28 Feb 2018
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park J, Block M, Bock D, Kalebo P, Nilsson P, Prytz M, Haglind E. A Comparison of Liver MRI and Contrast-Enhanced CT as Standard Workup Before Treatment for Rectal Cancer in Usual Care - A Retrospective Study. Curr Med Imaging. 2022;18(2):256-262. doi: 10.2174/1573405617666210712125028.
PubMed 34931986
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Imaging or CT Abdomen as Standard Work-up Before Treatment Planning for Rectal Cancer?
- ClinicalTrials.gov ID
- NCT03463616
- Acronym / sponsor ID
- MRvsCT
- Conditions
- Rectal Cancer, Liver Metastases
- Keywords
- Rectal Cancer, Liver Metastases, CT abdomen, MRI Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 13 Mar 2018 (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.
Rectal cancer is a common diagnosis. The prognosis after treatment has improved over the last decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical technique (TME) and, in certain cases, due to adjuvant therapy after surgery. For some 15-20 years, treatment of metastasis has changed; liver- and lung metastasis in certain situations are surgically removed, or in the liver, treated with ablation (radio-frequency). During the same period the possibilities for chemotherapy of metastatic disease have improved, with new drugs and more drug regimens.
These changes in treatment pathways have required changes in how patients with newly diagnosed rectal cancer are "worked up" pre-treatment. Starting in the early 2000s magnetic resonance imaging of the pelvic area has developed and is today mandatory to be able to adequately stage the tumour and plan for the multi-modal treatment before and after surgery.
In many hospitals the set-up is a combination of computed tomography of the abdomen and chest and to this a MRI of the pelvic organs is added, whereas others have adopted MRI also for the abdominal part, thus having an MRI of the liver for the diagnosis of liver metastasis initially, before surgery. For the chest organs, CT is still normative.
MRI has a higher sensitivity and specificity to detect liver metastasis, compared with CT. In order to plan the liver surgery/ablations, most liver surgeons rely on MRI for detailed information about the position of the metastasis and the relation to large vessels.
The aim of this study is to examine the possible differences in percentage of patients requiring further radiology examinations after basic set-up comparing the routine of initial MRI of abdomen (and pelvic organs) with the routine of initial CT of the abdomen (and MRI of the pelvic organs). Further included is an analysis of the rate of liver metastasis using the two different routines, and finally outcome over 12 months in terms of liver treatment for metastasis.
Detailed description
Background:
Rectal cancer is a common diagnosis in both men and women, more commonly occurring in men (60%) than women (40%). In Sweden some 2000 cases are diagnosed each year. The prognosis after treatment has improved over the last decades, partly due to neoadjuvant radio(chemo)therapy, but also due to improved surgical technique (TME) and, in certain cases, due to adjuvant therapy after surgery.
For some 15-20 years, treatment of metastasis has changed; liver- and lung metastasis in certain situations are surgically removed, or in the liver, treated with ablation (radio frequency). During the same period the possibilities for chemotherapy of metastatic disease have improved, with new drugs and more drug regimens.
These changes in treatment pathways have required changes in how patients with newly diagnosed rectal cancer are "worked up" pre-treatment. Starting in the early 2000s magnetic resonance imaging of the pelvic area has developed and is today mandatory to be able to adequately stage the tumour and plan for the multi-modal treatment before and after surgery.
In many hospitals the set-up is a combination of computed tomography of the abdomen and chest and to this a MRI of the pelvic organs is added, whereas others have adopted MRI also for the abdominal part, thus having an MRI of the liver for the diagnosis of liver metastasis initially, before surgery. For the chest organs, CT is still normative.
MRI has a higher sensitivity and specificity to detect liver metastasis, compared with CT. In order to plan the liver surgery/ablations, most liver surgeons rely on MRI for detailed information about the position of the metastasis and the relation to large vessels.
The objective of the study is to examine:
The possible differences in percentage of patients requiring further radiology examinations after basic set-up comparing the routine of initial MRI of abdomen (and pelvic organs) with the routine of initial CT of the abdomen (and MRI of the pelvic organs). Further included is an analysis of the rate of liver metastasis using the two different routines, and finally outcome over 12 months in terms of liver treatment for metastasis.
Hypothesis:
Primary:
- Patients who underwent initial abdominal MRI had a significantly lower need for additional radiology examinations compared with those who underwent initial CT abdomen.
Secondary:
- A higher proportion of patients who underwent initial abdominal MRI underwent liver treatment aiming for cure at 12 months.
- Abdominal MRI as initial examination resulted in a higher proportion of detected liver metastasis.
- Cost effectiveness analysis will show that initial abdominal MRI of the abdominal organs is cost-effective.
Design:
A retrospective study using clinical details such as date for diagnosis, clinical tumour stage, type of surgical treatment and date, pathology tumour stage, local recurrence and survival at 36 months from the Swedish ColoRectal Cancer Registry for patients with rectal cancer treated at Sahlgrenska University Hospital and Norra Älvsborg Hospital during the years collecting patients backwards from 2015-12-31 until sufficient number is reached (see below "Sample size").
Data will be collected in the radiology patient documentation at the two hospitals using the original radiology report for the index examinations as well as type and number of additional radiology examinations and the reports for those.
For patients with liver metastases in the original radiology report at the index work-up and in cases with indeterminate initial results, the original radiology examinations will be re-evaluated by one or if possible two radiologists.
Data from the clinical patient records on treatment plan (index treatment) and time and type of treatment for liver metastasis.
No direct contact with patients is planned, and only data already collected (see above) will be used.
Methodology:
Through Regional Cancer Center West (RCC Väst) appropriate data from to Swedish ColoRectal Cancer Register will be collected, consisting of age, time for diagnosis, time for multidisciplinary conference, time for oncological treatment, time for surgery, cTNM as well as pTNM, performed treatment/s within 12 months, recurrence/s and survival (3 years).
Data to be collected from radiology reports include presence of liver metastasis, number of liver metastasis, additional radiology examinations after index work-up - type and number as well as findings of liver metastasis. Additional findings of distant metastases to retro peritoneal lymph-nodes and to peritoneum will also be recorded.
Data from re-evaluation of examinations for all patients diagnosed with liver metastases such as number of metastases, number of small metastases (<10mm), metastases to retro peritoneal lymph-nodes and to peritoneum.
Data to be collected from hospital records for all patients include time line for different aspects of treatment including multidisciplinary conference (and decision), oncological treatment and liver surgery until 12 months from diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT abdomen | – | Radiation: CT abdomenPatients who had a CT abdomen as primary work-up before treatment planning for rectal cancer. |
| MRI Abdomen | – | Radiation: MRI abdomenPatients who had a MRI abdomen as primary work-up before treatment planning for rectal cancer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients in the Swedish Colo- Rectal Cancer Registry (SCRCR) and treated for rectal cancer at Sahlgrenska University Hospital and Norra Älvsborg Hospital 2013-2015.
Key inclusion criteria (1 listed)
- All patients in the Swedish Colo- Rectal Cancer Registry (SCRCR) and treated for rectal cancer at Sahlgrenska University Hospital and Norra Älvsborg Hospital 2013-2015.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CT abdomenCT scan of abdomen for metastasis staging of rectal cancer | Radiation | CT abdomen |
| MRI abdomenMRI of abdomen for metastasis staging of rectal cancer | Radiation | MRI Abdomen |
Primary outcome
Percentage of patients who needed additional radiology examination/s before treatment planning after routine MRI of abdominal organs compared with routine CT of abdominal organs.
Time frame: 3 months
5 secondary outcomes
Comparison of percentage of patients treated with liver surgery/ablation within 12 months between the two groups.
Time frame: 12 months
Comparison of the percentage of patients who were diagnosed with liver metastasis, between the two groups.
Time frame: 3 years
Cost effectiveness analysis of routine MRI of abdominal organs compared with routine CT of abdominal organs.
Time frame: 3 years
Overall survival after 3 years
Time frame: 3 years
Disease free survival after 3 years
Time frame: 3 years
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 20 Apr 2021.
- Derived from this study: PubMed 34931986Park J, Block M, Bock D, Kalebo P, Nilsson P, Prytz M, Haglind E. A Comparison of Liver MRI and Contrast-Enhanced CT as Standard Workup Before Treatment for Rectal Cancer in Usual Care - A Retrospective Study. Curr Med Imaging. 2022;18(2):256-262. doi: 10.2174/1573405617666210712125028.
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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.
Mattias Prytz, MD, PhD principal investigator
Sahlgrenska University Hospital
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 and Liver Metastases, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 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 20 Apr 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 Sweden. 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?
Percentage of patients who needed additional radiology examination/s before treatment planning after routine MRI of abdominal organs compared with routine CT of abdominal organs. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03463616, which also lists 1 linked publication.
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 20 Apr 2021.