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Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05687747
Collaborator
National University, Singapore (Other)
100
Enrollment
1
Arm
35
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Single centre prospective evaluation of 68Gallium(Ga68)-FAPI-46 PET/MRI in patients diagnosed with Hepatocellular Carcinoma (HCC). 68Gallium-FAPI-46 PET/MRI and standard contrasted multiphasic MRI imaging will be acquired in patients with radiological or histological diagnosis of HCC. The PET scan results will be compared to standard imaging to evaluate its role in lesion detection, characterisation and staging in patients with HCC.

Condition or Disease Intervention/Treatment Phase
  • Drug: Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Gallium-FAPI-46 PET/MRI

Patients receiving Ga68-FAPI-46 will be injected at a dose of 4mCi +/- 2mCi (0.05mCi/kg). Whole body PET scans will be acquired 45mins post injection from head to mid thighs

Drug: Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI
68Gallium-FAPI-46 PET/MRI is a novel radioactive diagnostic tracer used with Positron Emission Tomography imaging. It defects Fibroblast Activation Protein positive cancer cells and cancer associated fibroblasts.

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of FAPI-PET/MRI to detect intrahepatic HCC using contrasted multiphasic MRI liver as standard comparison [1 year]

    Calculated as: Number of MRI detected HCC lesions with FAPI-46 uptake / number of MRI detected intrahepatic HCC lesions

Secondary Outcome Measures

  1. Determine the proportion of cases whereby use of FAPI-46 PET/MRI leds to AJCC TNM/BCLC stage being, i) unchanged, ii) up-staged and iii) down-staged [1 year]

    Calculated as: number of HCC lesions identified on standard of care imaging with FAPI-46 uptake / total number of HCC lesions on standard of care imaging

  2. Sensitivity estimation of 68Gallium-FAPI-46 PET/MRI in per-lesion analysis for all lesions with available surgical resection samples for histopathology assessment [1 year]

    Calculated as: Number of pathologically confirmed HCC lesions identified on FAPI PET/MRI / total number of pathological confirmed HCC lesions

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age 21-99 years

  • Diagnosis of HCC based on histological assessment, or meeting consensus radiological criteria for diagnosis of HCC based on American Association for the Study of Liver Diseases practice guidelines(18)

  • No prior locoregional therapy for HCC

  • Creatinine clearance > 30ml/min based on Cockcroft Gault formula

  • Able to provide informed signed consent

Exclusion Criteria:

  • Allergy to 68Ga-FAPI contrast agents

  • Contraindication to MRI, including but not limited to MRI incompatible metallic implants, cardiac pacemaker, claustrophobia

  • Weight > 150kg

  • Known active malignancy other than HCC

  • Hepatic surgery within the last 30 days.

  • Active inflammatory conditions that may affect FAPI imaging in opinion of investigator. Including but not limited to active infection, IgG4-related disease, inflammatory bowel disease,

  • Pregnancy (all women of childbearing age are required to undertake a urine pregnancy test)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • National University Hospital, Singapore
  • National University, Singapore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT05687747
Other Study ID Numbers:
  • 2022/00487
First Posted:
Jan 18, 2023
Last Update Posted:
Jan 18, 2023
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National University Hospital, Singapore
Hepatocellular Carcinoma
68Ga-FAPI-46 PET/MRI
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
FAPI-46

Study Results

No Results Posted as of Jan 18, 2023