LiverMultiScan Analysis of MRI Scans in HCC

NCT04451603 | Completed

• 1 other identifier: LMS Liver
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This project is a pilot study to interrogate the potential of LMS as a predictive tool for the selection of therapy for HCC patients. The reliability of LMS to predict patients' response following HCC therapy will leverage on an algorithm that is built from the pool of MRI scans from HCC patients pre- and post-treatment. In the study, MRI scans of 30 HCC and metastatic colorectal cancer (CM) patients (ratio of 4:1) will be analysed. CM cancer patients include patients whose cancers metastasized from colorectal cancer or primary liver cancer. These patients will either receive one of the treatment, surgical resection, Y90 or systemic therapy. A total of 4 MRI scans will be taken for each patient; the first MRI scan will be taken within a month before treatment initiation and the remaining MRI scans will be taken at the 1st, 3rd and 9th month post-initiation of treatment.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Magnetic Resonance Imaging (MRI); LiverMultiScan (LMS); Prognostication; Predictive tool

Outcome Measures

Primary Outcomes (2)

• Correlation of cT1 with the development of liver-related morbidity such as decompression

  The objective is to predict the clinical outcomes of patients undergoing treatment

  From 6 weeks before start of treatment to the 9th month after start of treatment

• Use of prediction software or tools to estimate volume and health of the future liver remnant (FLR), monitor changes in liver volume and health post treatment

  The objective is to refine the prediction capabilities of these software or tools. The software used in this study is the LiverMultiScan (LMS) by Perspectum which will do post-analysis of patients' MRI scans.

  From 6 weeks before start of treatment to the 9th month after start of treatment

Study Arms (3)

Surgical resection

Procedure: Surgery

Y-90 therapy

Radiation: Radiation therapy

Systemic Therapy

Drug: Drug treatment

Interventions

Surgery PROCEDURE

Surgical resection of the liver

Surgical resection

Radiation therapy RADIATION

Y-90 radioembolization therapy is the main treatment

Y-90 therapy

Drug treatment DRUG

Examples include tyrosine kinase inhibitors and immune checkpoint inhibitors

Systemic Therapy

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants of the study are patients in National Cancer Centre who have HCC or CM. They are recruited because they will receive either one of the three treatments (surgical resection, Y90 treatment or systemic therapy). The patient will be approached to join the study during their consultation visit in NCC.

You may qualify if:

• Male and female patients, 21 to 90 years of age at the time of signing of the informed consent form.
• For HCC patients: Diagnosis of HCC confirmed by either 1 of the following 3 criteria:
• AASLD imaging criteria
• Histology/cytology of biopsy or surgically resected tumor tissue samples
• Space occupying lesion in the liver and serum alpha-fetoprotein (AFP) of more than 400 in patients with chronic viral hepatitis or cirrhosis of any cause
• For CM patients: Diagnosis of colorectal cancer with metastasis to the liver confirmed by histology/cytology.
• Has ECOG performance status 0-1 before treatment intervention.
• Surgical Resection
• Has received no anti-cancer specific treatment for HCC i.e. previous liver resection, loco-regional therapy (e.g. RFA, TACE, SIRT), radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy within 4 weeks prior to the date of the planned surgery.
• Has adequate bone-marrow reserve, renal function and hepatic function as assessed by standard laboratory criteria:
• Absolute neutrophil count ≥ 1.0 x 10\^9/L
• Platelet count ≥ 50 x 10\^9/L
• Haemoglobin ≥ 9.0 g/dL
• INR ≤ 2.0
• Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN)

You may not qualify if:

• Has low creatinine clearance (estimated glomerular filtration rates \< 60)
• Is unable to return for follow-up visits to monitor for disease response/progression
• Is unable to have a MRI scan, including but not limited to claustrophobia, implanted metallic devices and metal foreign bodies
• Non-provision of informed consent
• For female patients: pregnant or lactating
• Surgical resection
• Has encephalopathy.
• Has received a major organ allograft.
• Has an uncontrolled bleeding disorder.
• Has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
• Has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the study procedures.
• Has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
• Y90 treatment
• o Nil
• Systemic therapy

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Perspectum: collaborator

Study Sites (1)

National Cancer Center Singapore

Singapore, 169690, Singapore

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Pierce Chow

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: June 30, 2020
• Study Start: October 19, 2018
• Primary Completion: March 16, 2021
• Study Completion: December 31, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)