B-mode Ultrasound Imaging in Detecting Early Liver Cancer

NCT02774161 | Completed DMC

• 3 other identifiers: IRB-36299NCI-2016-00663GIIMG0007
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Early Hepatocellular Carcinoma; Fibrosis; Stage I Hepatocellular Carcinoma; Stage II Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• Mid-band fit

  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.

  Up to 16 months

• Spectral intercept

  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.

  Up to 16 months

• Spectral slope

  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.

  Up to 16 months

Study Arms (1)

Diagnostic (B-mode ultrasound imaging)

EXPERIMENTAL

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

Other: Ultrasound Tomography

Interventions

Ultrasound Tomography OTHER

Undergo B-mode ultrasound imaging

Diagnostic (B-mode ultrasound imaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Fibrosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Aya Kamaya

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 17, 2016
• Study Start: May 1, 2016
• Primary Completion: June 19, 2017
• Study Completion: June 19, 2017
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

US (1)