MRI Imaging or CT Abdomen as Standard Work-up Before Treatment Planning for Rectal Cancer?

NCT03463616 | Completed

• 1 other identifier: MRvsCT
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rectal Cancer; Liver Metastases

Keywords

Rectal Cancer; Liver Metastases; CT abdomen; MRI Liver

Outcome Measures

Primary Outcomes (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.

  3 months

Secondary Outcomes (5)

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

  12 months

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

  3 years

• Cost effectiveness analysis of routine MRI of abdominal organs compared with routine CT of abdominal organs.

  3 years

• Overall survival after 3 years

  3 years

• Disease free survival after 3 years

  3 years

Study Arms (2)

CT abdomen

Patients who had a CT abdomen as primary work-up before treatment planning for rectal cancer.

Radiation: CT abdomen

MRI Abdomen

Patients who had a MRI abdomen as primary work-up before treatment planning for rectal cancer.

Radiation: MRI abdomen

Interventions

CT abdomen RADIATION

CT scan of abdomen for metastasis staging of rectal cancer

CT abdomen

MRI abdomen RADIATION

MRI of abdomen for metastasis staging of rectal cancer

MRI Abdomen

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska university hospital

Gothenburg, SE 416 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34931986 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mattias Prytz, MD, PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 13, 2018
• Study Start: March 15, 2018
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 20, 2021

Record last verified: 2021-04

Locations

SE (1)