Official Title
Precision Medicine for Liver Tumours With Quantitative Magnetic Resonance Imaging and Whole Genome Sequencing
Brief Title
Precision Medicine for Liver Tumours With Quantitative Magnetic Resonance Imaging and Whole Genome Sequencing
Protocol ID
NCT04597710
Lead Sponsor
Perspectum
Brief 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
Study Period
-
Enrollment Count
200 participants
Eligibility Criteria
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.
Filters
Liver Cancer
Liver Metastasis Colon Cancer
ACTIVE_NOT_RECRUITING
ADULT
OLDER_ADULT