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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

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.

Locations (1)

Sahlgrenska University Hospital/Östra
Gothenburg, Sweden