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Precision Medicine for Liver Tumours With Quantitative Magnetic Resonance Imaging and Whole Genome Sequencing

NCT04597710 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-12-01

No results posted yet for this study

Summary

This will be a prospective, observational, cohort study to determine the impact of integrated diagnostics using quantitative magnetic resonance imaging, whole genome sequencing and digital pathology on intended patient management for liver cancer patients referred for liver resection.

Participants with primary or secondary liver cancer will be recruited from Hampshire Hospitals NHS Foundation Trust in Basingstoke or Oxford University Hospitals NHSFoundation Trust in Oxford. The incidence of treatable liver tumours is on the rise globally, driven by obesity, viral hepatitis and metastases from colorectal cancers. Survival rates can be improved with optimised allocation of treatment options including surgical resection, radiofrequency ablation, embolisation, chemotherapy and targeted molecular therapies (including immunotherapy).

The key motivation of this study is to help patients access the most suitable treatment combinations, based on integrating clinical, radiological and genomic data. A similar integrated approach, integrating radiology and pathology, has been shown to improve outcomes in breast cancer care. Detailed pathologic analysis of the surgical specimen from breast carcinoma biopsy provides valuable feedback to the radiologist, establishes the completeness of surgical intervention, and generates predictive information for therapeutic decisions. Whole genome sequencing (WGS) has discovered cancer driver mutations and the complex molecular profile of liver cancer. In many metastatic solid tumours, WGS has been used to identify a significant patient population (31%) who present with a biomarker that predicts sensitivity to a drug and lacked any known resistance biomarkers for the same drug. Identifying which patients possess druggable mutations will allow clinicians to make the optimal treatment decisions. The next challenge is integrating WGS into scalable clinical practice

Conditions

Interventions

GENETIC

utility of whole genome sequencing (WGS) to aid clinical decision making in patients referred for liver resection

All participants will attend their planned outpatient surgery appointment.The consultant will document the intended treatment plan for each participant in line with their usual care pathway.Following this, participants will be required to attend three dedicated study visits:The results of the MRI scans from Study Visit 1 will be analysed into a LiverMultiScan report.A report will be sent to the consultant who will review their original documented care plan alongside the LiverMultiScan report.The consultant may update the intended care plan as a result of the LiverMultiScan report, in line with the device CE-marking.Any changes to the care plan will be documented.The patient will then undergo their planned treatment.The tumour explant will be collected and samples will be stored, transported and processed for genetic sequencing and digital histopathology.Study Visit 2 will be performed remotely 12 months following their planned treatment,where patient reported outcomes will be collected

Sponsors & Collaborators

  • Perspectum

    lead INDUSTRY

Principal Investigators

  • Rajarshi Banerjee · Perspectum Ltd

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-18
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597710 on ClinicalTrials.gov