FDGal PET/CT to Detect Hepatocellular Carcinoma

• Status: Withdrawn
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Liver cancer is one of the leading causes of cancer death among Asian men. If diagnosed early the disease is treatable with surgery. Current conventional imaging modalities have limitations to early detection. This study proposes to use 18F-FGal and 18F-FDG PET/CT scans to compare the clinical efficacy of diagnosing hepatocellular carcinoma (a type of liver cancer) using these PET/CT scans.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Treatments: Fluorodeoxyglucose F18

Criteria

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.