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OpenTrials
Completed

NCT Number: NCT00081094

Positron Emission Tomography Using Carbon-11 Acetate and Fludeoxyglucose F 18 in Detecting Hepatocellular Carcinoma (Liver Cancer) in Patients With Known or Suspected Liver Cancer

RATIONALE: Imaging procedures, such as carbon-11 acetate positron emission tomography (PET) and fludeoxyglucose F 18 PET, may improve the ability to detect hepatocellular carcinoma (liver cancer) and allow doctors to plan the most effective treatment.

PURPOSE: This clinical trial is studying how well carbon-11 acetate PET and fludeoxyglucose F 18 PET work in detecting cancer in patients with liver cancer.

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Key information

Conditions

Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION:

  • Biopsy-proved HCC (stage I and II by conventional staging) or one or more of the following in a patient with clinically documented cirrhosis:
  • AFP > 200 mg/dL;
  • A contrast-enhancing tumor mass (>1 cm) by CT or MRI; or
  • A tumor mass confirmed by arteriography.
  • Patient must provide written informed consent and have completed conventional imaging and staging before initiation of PET imaging.

EXCLUSION:

  • Pediatric patients under the age of 18 will be excluded from consideration from this study.
  • Patients with a known prior malignancy (with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years will be excluded from entry into the study. However, patients with a prior HCC thought to have a new primary or recurrent HCC are eligible.
  • Pregnant and breastfeeding patients.
  • Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)

Treatment and study plan

18F-Fluorodeoxyglucose-PET (FDG-PET)

Procedure

11Carbon-Acetate-PET

Procedure

Primary outcomes

  1. Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18

Secondary outcomes

  1. Determine whether PET identifies additional sites of disease not detected by conventional imaging

  2. Obtain a preliminary estimate of the impact of PET on management of patients with HCC.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Detection of Hepatocellular Carcinoma by Positron Emission Tomography With C-Acetate-11 and F-fluorodeoxyglucose-18

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Apr 8, 2004
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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