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Completed

NCT Number: NCT02774161

B-mode Ultrasound Imaging in Detecting Early Liver Cancer

This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.

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Key information

Conditions

Cirrhosis Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Early Hepatocellular Carcinoma Fibrosis Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Stage I Hepatocellular Carcinoma Stage II Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, School of Medicine

Palo Alto, California, 94305, United States

About this study

PRIMARY OBJECTIVES:

I. To investigate the use of quantitative ultrasound spectroscopy to detect early hepatocellular carcinoma (HCC) as an inexpensive and widely available quantitative (i.e. robust) method to confirm disease in developing countries.

OUTLINE:

Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For Healthy Volunteers

  • Patients over 18 years of age.
  • Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures.

For HCC patients

  • Patients over 18 years of age.
  • Patient with confirmed diagnosis of HCC, and untreated or Patients with Suspected HCC (Suspected HCC nodules should preferably be smaller than 3 cm and preferably within 6 cm in depth of the transducer head to minimize attenuation) and untreated or Patients at a higher risk of HCC undergoing a screening program by Ultrasound.

Exclusion criteria

For Healthy volunteers

  • Patients who are not likely to comply with the protocol requirements.

For HCC patients

  • Patients should not be taking other Investigational Agents.
  • Concomitant medications for treatment of the target lesion.

Treatment and study plan

Ultrasound Tomography

Other

Undergo B-mode ultrasound imaging

Primary outcomes

  1. Mid-band fit

    Time frame: Up to 16 months

    The Mid-band fit is related to the intensity of the returned ultrasound signal at different frequencies has been shown to change with tissue morphology.

  2. Spectral intercept

    Time frame: Up to 16 months

    Spectral intercept (SI) is mostly related to the number scatterers and their density in the tissue. Changes in the SI have been demonstrated to occur due to different pathologies and result from treatments that change the structure of the tissue being imaged.

  3. Spectral slope

    Time frame: Up to 16 months

    Summarized as the maximum and/or average value over the lesion of interest (using a region of interest selection) and the liver image as a whole.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Quantitative Ultrasound Spectroscopy to Early HCC

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2016
Registry last updated
Aug 3, 2021

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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