Recruiting NCT05687747
Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiolabelled tracer, 68Gallium-FAPI-46 PET/MRI.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 21 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Sensitivity of FAPI-PET/MRI to detect intrahepatic HCC using contrasted multiphasic MRI liver as standard comparison [Time frame: 1 year]
Secondary outcome measures (2)
- 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 [Time frame: 1 year]
- Sensitivity estimation of 68Gallium-FAPI-46 PET/MRI in per-lesion analysis for all lesions with available surgical resection samples for histopathology assessment [Time frame: 1 year]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Singapore · 1 center
- Robert John Walsh — Singapore
Publications
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- Wang G, Zhu S, Li X. Comparison of values of CT and MRI imaging in the diagnosis of hepatocellular carcinoma and analysis of prognostic factors. Oncol Lett. 2019 Jan;17(1):1184-1188. doi: 10.3892/ol.2018.9690. Epub 2018 Nov 12. PMID 30655882
- Wong S. Update on Positron Emission Tomography for Hepatocellular Carcinoma. Hong Kong J Radiol. 2017;20:192-204.
- Aertgeerts K, Levin I, Shi L, Snell GP, Jennings A, Prasad GS, Zhang Y, Kraus ML, Salakian S, Sridhar V, Wijnands R, Tennant MG. Structural and kinetic analysis of the substrate specificity of human fibroblast activation protein alpha. J Biol Chem. 2005 May 20;280(20):19441-4. doi: 10.1074/jbc.C500092200. Epub 2005 Apr 4. PMID 15809306
- Koustoulidou S, Hoorens MWH, Dalm SU, Mahajan S, Debets R, Seimbille Y, de Jong M. Cancer-Associated Fibroblasts as Players in Cancer Development and Progression and Their Role in Targeted Radionuclide Imaging and Therapy. Cancers (Basel). 2021 Mar 4;13(5):1100. doi: 10.3390/cancers13051100. PMID 33806468
- Wang XM, Yu DM, McCaughan GW, Gorrell MD. Fibroblast activation protein increases apoptosis, cell adhesion, and migration by the LX-2 human stellate cell line. Hepatology. 2005 Oct;42(4):935-45. doi: 10.1002/hep.20853. PMID 16175601
- Ju MJ, Qiu SJ, Fan J, Xiao YS, Gao Q, Zhou J, Li YW, Tang ZY. Peritumoral activated hepatic stellate cells predict poor clinical outcome in hepatocellular carcinoma after curative resection. Am J Clin Pathol. 2009 Apr;131(4):498-510. doi: 10.1309/AJCP86PPBNGOHNNL. PMID 19289585
- Henry LR, Lee HO, Lee JS, Klein-Szanto A, Watts P, Ross EA, Chen WT, Cheng JD. Clinical implications of fibroblast activation protein in patients with colon cancer. Clin Cancer Res. 2007 Mar 15;13(6):1736-41. doi: 10.1158/1078-0432.CCR-06-1746. PMID 17363526
Identifiers
NCT: NCT05687747 · 2022/00487