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

NCT05215535 | Recruiting

• 1 other identifier: Limerick
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; radiological examination liver

Outcome Measures

Primary Outcomes (2)

• Need for supplementary radiologic liver examination

  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

  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 Outcomes (4)

• Time to start of treatment

  12 months

• Recurrence of rectal cancer

  12 months

• Liver metastasis

  36 months

• Survival

  36 months

Study Arms (2)

MRI group

EXPERIMENTAL

An abbreviated MRI of the liver/abdomen

Radiation: Abbreviated MRI of the liver/abdomen

CT group

ACTIVE COMPARATOR

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

Interventions

Abbreviated MRI of the liver/abdomen RADIATION

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.

MRI group

Combined single venous and 3 min equilibrium phase CT of the abdomen/liver RADIATION

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.

CT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska University Hospital/Östra

Gothenburg, Sweden

RECRUITING

Related Publications (4)

• Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, Aranda Aguilar E, Bardelli A, Benson A, Bodoky G, Ciardiello F, D'Hoore A, Diaz-Rubio E, Douillard JY, Ducreux M, Falcone A, Grothey A, Gruenberger T, Haustermans K, Heinemann V, Hoff P, Kohne CH, Labianca R, Laurent-Puig P, Ma B, Maughan T, Muro K, Normanno N, Osterlund P, Oyen WJ, Papamichael D, Pentheroudakis G, Pfeiffer P, Price TJ, Punt C, Ricke J, Roth A, Salazar R, Scheithauer W, Schmoll HJ, Tabernero J, Taieb J, Tejpar S, Wasan H, Yoshino T, Zaanan A, Arnold D. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016 Aug;27(8):1386-422. doi: 10.1093/annonc/mdw235. Epub 2016 Jul 5.

  PMID: 27380959 BACKGROUND

• Achiam MP, Logager VB, Skjoldbye B, Moller JM, Lorenzen T, Rasmussen VL, Thomsen HS, Mollerup TH, Okholm C, Rosenberg J. Preoperative CT versus diffusion weighted magnetic resonance imaging of the liver in patients with rectal cancer; a prospective randomized trial. PeerJ. 2016 Jan 14;4:e1532. doi: 10.7717/peerj.1532. eCollection 2016.

  PMID: 26793420 BACKGROUND

• Niekel MC, Bipat S, Stoker J. Diagnostic imaging of colorectal liver metastases with CT, MR imaging, FDG PET, and/or FDG PET/CT: a meta-analysis of prospective studies including patients who have not previously undergone treatment. Radiology. 2010 Dec;257(3):674-84. doi: 10.1148/radiol.10100729. Epub 2010 Sep 9.

  PMID: 20829538 BACKGROUND

• Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.

  PMID: 23485231 BACKGROUND

Related Links

• National Cancer Care Guidelines for Colorectal Cancer \[National Cancer Care Guidelines\].

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Liver Extracts

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

Intervention Hierarchy (Ancestors)

Tissue Extracts; Complex Mixtures

Study Officials

• Jennifer Park, MD, PhD

  Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Park, MD, PhD

CONTACT

+46-31-3436780; jennifer.park@vgregion.se

Elisabeth González, RN

CONTACT

+46-31-343 64 62; elisabeth.gonzales@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: It will not be possible to mask for either patients nor participating health care professionals if patients are enrolled in the control- or intervention group. Hence, the study will not be blinded. When the final data analysis is performed for the primary outcome measure the person performing the analysis will not be aware of which group each patient was a part of.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Consenting patients with newly diagnosed rectal cancer who fulfil the inclusion criteria and no exclusion criteria will be randomized into two groups with regard to radiological investigation of the liver; Intervention: An abbreviated MRI of the liver/abdomen Control: A combined single venous and 3 min equilibrium phase CT of the abdomen/liver Randomization will be conducted in blocks of 6, and stratified for sex and hospital.

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 31, 2022
• Study Start: April 12, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)