A clinical trial of liver 99mTc-phytate scintigraphy in the diagnosis of nonalcoholic steatohepatitis

UMIN ID: UMIN000000787

Registered date:01/04/2013

Basic Information

• Health condition(s) or Problem(s) studied: nonalcoholic steatohepatitis
• Date of first enrollment: 2007/01/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Duration: five years Patients, who will undergo liver biopsy for clinical suspicion of nonalcoholic steatohepatitis (NASH), will be enrolled in this study. The patients will take 99mTc-phytate scintigraphy examination at the time of liver biopsy. The aim of this study is to identify the liver 99mTc-phytate scintigraphy findings in patients with biopsy-proven "NASH"and "not NASH", and to assess their correlations with the clinicopathological variables.

Outcome(s)

• Primary Outcome: The values of colloid uptake in liver, spleen, and heart in the 99mTc-phytate colloid scintigraphy

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: The patients who have no normal judgement ability for informed consent. The patients who have past history of allergy to 99mTc-phytate or kind medicine. The patients who are pregnant or will doubtfully be pregnant. The patients who the treating doctors decide are inadequate to enrollment to this trial.

Related Information

• Primary Sponsor: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
• Source(s) of Monetary Support: None