IP10-COMPACT
Research type
Research Study
Full title
Comparing pOrtable MRI and TRUS-Fusion Prostate biopsy to Assess aCcuracy of prostate cancer detection (IP10-COMPACT)
IRAS ID
327368
Contact name
Taimur Shah
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Currently patients suspected of having prostate cancer undergo an MRI followed by targeted biopsies of any suspicious lesions under trans-rectal ultrasound (TRUS) guidance. This pathway is labour, time and cost intensive. Additional, TRUS-MRI-Fusion devices are needed which overlay the MRI scan onto the TRUS which is used for biopsies. This can lead to targeting errors due mismatched images. Although biopsies can be performed in the MRI scanner to reduces these errors it requires significant amount of time within an expensive MRI scanner within the radiology department, along with special MRI compatible equipment. Portable MRI technology has the potential to reduce these errors and reduce the diagnostic pathway to one visit. The Promaxo portable MRI is an FDA cleared MRI device for MR-guided procedures. It uses a novel “truly” open MRI with an unobstructed field of view and central aperture for robotic guided intervention and has a limited footprint allowing it to be places in a standard operating theatre or large clinic room. The strength of magnet is also low enough that special precautions and equipment are not to take biopsies.
We want to conduct a study that answer the following research question: How does the accuracy of targeted biopsies of the prostate performed under the guidance of a portable MRI scanner compare to TRUS-MRI-fusion biopsies?
Design: A single arm, singe centre IDEAL stage 2a study (n=85 patients) of patients undergoing prostate biopsy for suspected prostate cancer where each patient would undergo both a portable MRI registered biopsy and a TRUS-image-fusion biopsy. To reduce the risk of bias between the two modalities the order of the modality will be randomised 1:1. There will be no blinding of the surgeon.
Primary outcome will be technical feasibility of performing portable MRI and portable MRI targeted biopsies and estimates on cancer detection.
REC name
London - Surrey Research Ethics Committee
REC reference
24/LO/0253
Date of REC Opinion
3 May 2024
REC opinion
Further Information Favourable Opinion