NCT03839706

Brief Summary

Liver transplantation is the standard treatment for patients with early-stage Hepatocellular Carcinoma (HCC). Currently, important treatment decisions, like the selection of patients for transplantation, are made on crude, static tumour characteristics such as the size and number of lesions that do not reflect other aspects of tumour biology. To date, pre-transplantation percutaneous biopsy is the best strategy to assess tumoral differentiation and, consequently, tumor biological behavior. Previous studies have demonstrated that 18F-Fluorodeoxyglucose Positron Emission Tomography Magnetic Resonance Imaging (18F-FDG PET/MRI) may have role in assessing the HCC tumoral differentiation and predict survival after LT. The Investigators will assess the accuracy of 18F-FDG PET/MRI as a tool to predict HCC recurrence after liver transplant. To understand the role of 18F-FDG PET/MRI in prediction of HCC's biological behavior and upon recurrence, the investigators will try to assess whether the findings in 18F-FDG PET/MRI can predict HCC poor tumoral differentiation, if the findings in 18F-FDG PET/MRI are related to presence of circulating tumoral DNA in plasma and try to determine the role of 18F-FDG PET/MRI in predicting HCC recurrence after resection. These findings may impact the selection criteria for liver transplantation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

3.9 years

First QC Date

January 12, 2019

Last Update Submit

December 5, 2023

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 18F-FDG PET/MRI results can identify aggressive HCC behavior and recurrence post transplant

    PET scan results will be compared with pathology at the time of transplant. Patients will be followed-up 2 years post transplant for recurrence. PET scan results will be compared for Recurrent/non-recurrent patients.

    3 years

Secondary Outcomes (2)

  • 18F-FDG PET/MRI can predict HCC's poor tumoral differentiation

    3 years

  • 18F-FDG PET/MRI are related to presence of circulating tumor DNA in plasma

    3 years

Study Arms (1)

PET MRI Arm

EXPERIMENTAL

Patient enrolled in the study will have a PET MRI exam scheduled before transplant

Device: PET MRI

Interventions

PET MRIDEVICE

18F-Fluorodeoxyglucose Positron Emission Tomography combined with Primovist MRI

PET MRI Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histological or radiological diagnosis of HCC (AASLD guidelines)
  • Listed for LT at UHN
  • Enrolled in ctDNA study (15-5925)
  • Able to undergo PET and MRI examination,
  • Willingness and ability of patient to provide signed voluntary informed consent.
  • Adults (age ≥ 18-years old)

You may not qualify if:

  • Any contraindication to undergoing venipuncture.
  • Patients with previous history of cancer diagnosed and/or treated within last 5 years, with the exception of non-melanomatous skin cancers and intraepithelial cancers such as cervical intraepithelial neoplasia that were properly treated, are not eligible.
  • Inability to lie supine for at least 30 minutes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2019

First Posted

February 15, 2019

Study Start

August 22, 2018

Primary Completion

July 30, 2022

Study Completion

September 1, 2024

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations

CA(1)