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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Sweden1 site
  • Sahlgrenska university hospital

    Gothenburg, SE 416 85

Other trials in Sweden

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.

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 groups in NCT03463616
Study groupRoleWhat they receive
CT abdomenPatients who had a CT abdomen as primary work-up before treatment planning for rectal cancer.
Receives: Radiation: CT abdomen
MRI AbdomenPatients 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.

  1. 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)
  1. Comparison of percentage of patients treated with liver surgery/ablation within 12 months between the two groups.

    Measured: 12 months

  2. Comparison of the percentage of patients who were diagnosed with liver metastasis, between the two groups.

    Measured: 3 years

  3. 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

  4. Overall survival after 3 years

    Measured: 3 years

  5. 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.

  1. First posted13 Mar 2018
  2. Study start15 Mar 2018
  3. Primary completion31 Mar 2020
  4. Study completion31 Dec 2020

Resources

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)
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

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.

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