Liver Magnetic Resonance Imaging Before Treatment for Rectal Cancer. A Randomised Controlled Trial. (Limerick)

April 26, 2022 updated by: Vastra Gotaland Region

Limerick - Liver Magnetic Resonance Imaging Before Treatment for Rectal Cancer. A Randomised Controlled Trial.

This multicentre randomized controlled trial aims to investigate whether an abbreviated MRI is comparable to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver, in the pretreatment radiological workup in patients with rectal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of rectal cancer in the European Union is approximately 125 000 per year, constituting a third of the total colorectal cancer incidence(1). In Sweden approximately 2000 individuals are diagnosed with rectal cancer each year. Evaluation of patients and possible treatment strategies (including neo-adjuvant chemo/radiotherapy, choice of surgical technique and adjuvant chemotherapy) are based on tumor specific characteristics together with patient factors such as general condition and comorbidity. These characteristics include tumor, lymph node and metastasis classification (cTNM), height of tumor (distance from anal verge), engagement of circumferential margin or mesorectal fascia, signs of extramural invasion and the presence of distant metastases. Clinical examination and endoscopy together with magnetic resonance imaging (MRI) of the pelvic region are essential in the local staging process, where MRI provides the most accurate radiological assessment, especially for rectal tumors in stage T3 and T4. The recommended methods regarding evaluation of metastases (M stage) include contrast enhanced computed tomography (CT) or MRI of the liver/abdomen, CT of the thorax, and in selected cases positron emission tomography (PET)- CT, if extensive extramural vascular invasion is present.

Previous studies have investigated the efficiency of MRI compared to other radiological methods and found that MRI of the liver is superior to contrast enhanced CT, in terms of specificity and sensitivity for diagnosis of liver metastasis (both per patient and per lesion).

Even though MRI has been recommended as the first line modality for evaluating colorectal cancer liver metastases in patients who have not previously undergone therapy the Swedish national guidelines, as well as the European Society for Medical Oncology (ESMO), include recommendations of single venous phased contrast enhanced CT of the liver/abdomen in the pre-treatment radiological workup. Progress within diagnostics has led to development of CT examination with an additional 3 min equilibrium phase of the liver that may be added to the single venous phase in order to increase the sensitivity and specificity of the diagnosis of liver metastases. However, this has not yet been included in guidelines nor implemented on a national basis in the pre-treatment radiological workup in patients with colorectal cancer.

Objective The primary objective of the present study is to compare percentage of patients requiring further radiological examinations after index examination (due to inconclusive results) between patients randomized to an abbreviated MRI liver protocol and patients randomized to a combined single venous phase CT with an additional 3 min equilibrium phase of the liver. A secondary aim is to compare time to treatment initiation, survival and development of liver metatstases between patients randomized to either an abbreviated MRI or a combined single-venous phase CT with an additional 3 min equilibrium phase of the liver.

The study is a multicentre randomized controlled trial where the hypothesis is that there is no clinical difference between the two groups, and the study is designed as a non inferiority trial.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults >18 years of age
  • Endoscopically or clinically diagnosed with (suspected) rectal cancer and considered for further radiological investigation
  • Are able to understand trial information and provide oral and written consent

Exclusion Criteria:

  • Patients unable to undergo MRI (causes may include claustrophobia, presence of pacemaker or certain metal components in their body).
  • Patients diagnosed with benign disease of the rectum or squamous cell carcinoma
  • Patients diagnosed with recurrent rectal cancer
  • Patients unable to understand the trial information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI group
An abbreviated MRI of the liver/abdomen
Radiation: Abbreviated MRI of the liver/abdomen

The MRI examinations of the liver/abdomen will be performed at the same time as the pelvic MRI. A 1,5 T scanner will be used together with a dedicated torso/abdominal coil. An abbreviated MRI liver protocol includes 3 different sequences as follows:

  1. Axial T2-weighted respiratory triggered sequence with 5 mm slice thickness.
  2. Axial diffusion weighted spin echo respiratory triggered sequence with fatsat with b-factors 50/800 s/mm2 and ADC calculation maps, 5 mm slice thickness
  3. An axial breath-hold 3D T1-weighted gradient echo with fatsat with 4 mm slice thickness, gap 2 mm, contrast enhanced venous phase and in a 3 min equilibrium phase, using regular i.v bolus injection of gadolinium contrast medium with standard clinical dose.
Active Comparator: CT group
A combined single venous and 3 min equilibrium phase CT of the abdomen/liver
Radiation: Combined single venous and 3 min equilibrium phase CT of the abdomen/liver
The CT examination of the liver will be performed as a combined examination in a single venous phase starting with the thoracic region directly followed by the abdomen down to the pelvis. An additional 3 min equilibrium phase of the liver only will end the examination. Regular iodinated low-osmolar non-ionic contrast media will be used of 350 mg I/ml using a power injector, 2-4 ml/s, 100-150 ml dependent on patient weight and kidney function. Reconstructed images in axial, coronal and sagittal plane will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for supplementary radiologic liver examination
Time Frame: 3 months
Number of patients in need for supplementary radiologic liver examination/s before treatment decision, after index examination (CT or MRI) of the abdominal organs, due to inconclusive results.
3 months
Cost effectiveness
Time Frame: 12 months
Costs related to all index radiological examinations will be included. Costs will be collected from national sources such as the Swedish association of local authorities and regions (SKR - Sveriges kommuner och regioner) whenever possible and alternatively from Sahlgrenska university hospital cost-per-patient files. Possibly a more complex model will be relevant depending on outcome, where total health care costs are compared between the two radiological work-up routines. Such an analysis will take survival into account.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 36 months
Overall survival
36 months
Time to start of treatment
Time Frame: 12 months
Time from index radiological workup to start of treatment
12 months
Recurrence of rectal cancer
Time Frame: 12 months
Number of patients with recurrence of rectal cancer (local or metastatic disease)
12 months
Liver metastasis
Time Frame: 36 months
Number of patients diagnosed with liver metastasis
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Investigators

  • Principal Investigator: Jennifer Park, MD, PhD, Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2022

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

December 15, 2021

First Submitted That Met QC Criteria

January 28, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2022

Last Update Submitted That Met QC Criteria

April 26, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Limerick

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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