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Completed

NCT Number: NCT04597710

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

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

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Metastasis Colon Cancer Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Basingstoke and North Hampshire Hospital

Basingstoke, Hampshire, RG249NA, United Kingdom

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female 18 years of age and older willing and able to give informed consent to participate in the study
  • Patients being considered for liver resection for primary or secondary liver cancer.

Exclusion criteria

  • The participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to pregnancy, a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia).
  • Any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.

Treatment and study plan

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

Genetic

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

Primary outcomes

  1. Proportion of patients for whom clinically-actionable data is provided by whole genome sequencing at the time of surgery.

    Time frame: 36 months

    This will be evaluated retrospectively, with clinically-actionable data defined as data which would result in a clinician choosing a different medical intervention to the current standard of care.

Secondary outcomes

  1. Proportion of patients for whom clinically-actionable data is provided by LiverMultiScan.

    Time frame: 36 months

    . To determine the utility of quantitative multiparametric MRI with LiverMultiScan to aid clinical decision making in patients referred for liver resection.

  2. Correlation of computationally-derived digital pathology results with human pathologist assessments of the tumour and non-tumour tissue, along with assessment of intra- and inter-rater variability.

    Time frame: 36 months

    To compare computationally-derived digital pathology results with human pathologist assessments of the tumour and non-tumour tissue.

  3. Correlation of MR measurements of steatosis and fibroinflammation with digital pathology and human pathology.

    Time frame: 36 months

    To compare histopathological assessments of liver fat and fibroinflammation with quantitative MRI metrics (cT1, PDFF)

  4. Performance of WGS and LiverMultiScan for predicting post-surgery length of stay in hospital, post-operative liver function, 1-year mortality and recurrence rates.

    Time frame: 36 months

    To evaluate the long term outcomes and recurrence rates and recurrence patterns of patients as it relates to imaging and whole genome sequencing.

  5. Proportion of patients for whom actionable biomarkers of drug sensitivity are identified with WGS.

    Time frame: 36 months

    To evaluate whether whole genome sequencing enables better stratification of patients prior to surgery.

Sponsors and collaborators

Lead sponsor

Perspectum

Industry

Registry information

Acronym: Precision1

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2020
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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