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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2023 |
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Main ID: |
NCT02899325 |
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Date of registration:
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09/09/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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FDGal PET/CT to Detect Hepatocellular Carcinoma
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Scientific title:
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A Single-blind Study to Evaluate the Efficacy and Safety of 18F-Fluorodeoxygalactose (18F-FDGal) Compared to 18F-Fluorodeoxyglucose (18F-FDG) to Detect Hepatocellular Carcinoma Via PET/CT in Patients With Cirrhosis or Chronic Liver Disease |
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Date of first enrolment:
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October 2019 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02899325 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Canada
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Contacts
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Name:
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Francois Benard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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British Columbia Cancer Agency |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female, age = 19 years of age.
- Patient who accepts to enter the study by signing written informed consent.
- Patient with performance status = 2 Eastern Cooperative Oncology Group (ECOG).
- Patient with cirrhosis or chronic liver disease suspected to have at least 1 hepatic
nodule larger than 1 cm in diameter detected by conventional image (US, CT, MRI).
- Hepatic nodule is defined as any one of the following conditions: suspicious
hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal
nodular hyperplasia, possible metastatic lesions from other primary malignancy.
Exclusion Criteria:
- Patient has serious allergic history or known allergy to 18F-FDGal or 18F-FDG.
- Patient has received therapy for aforementioned diagnosis before the PET scans
- Patient with known (proven) metastases from a prior malignancy
- Patient has been diagnosed with multiple malignancies.
- Female patient who is pregnant, lactating or planning to become pregnant during the
study.
- Patient has participated in other investigational trials within 28 days prior to study
enrollment.
- Inability to lie supine for the duration of the imaging studies.
- Subject with active systemic infections, or medical conditions that may significantly
affect adequate uptake and elimination of radiotracer.
- Subject with conditions judged by the investigator as unsuitable for the study.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liver Cirrhosis
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Chronic Liver Disease
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Hepatocellular Carcinoma
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Intervention(s)
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Drug: Diagnostic PET/CT scans
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Primary Outcome(s)
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Sensitivity of 18F-FDGal in the diagnosis of HCC on per-patient basis
[Time Frame: 6 months]
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Secondary Outcome(s)
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Sensitivity of 18F-FDGal in the diagnosis of HCC on per-site basis
[Time Frame: 6 months]
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Specificity of 18F-FDGal in the diagnosis of HCC
[Time Frame: 6 months]
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Number of participants with 18F-FDGal-related adverse events as assessed by abnormal vital sign measurement
[Time Frame: 1 hour]
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Secondary ID(s)
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H16-01905
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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