Trial Search Results

ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk

The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Exact Sciences Corporation

Intervention(s):

  • Device: Study CT/MRI Imaging
  • Device: Standard of Care CT/MRI Imaging
  • Diagnostic Test: Oncoguard™ Liver Test

Eligibility


Inclusion Criteria:

   1. Be 18 years of age or older.

   2. Understand the study procedures, be able to provide written informed consent to
   participate in the study, and have authorization for release of data, including
   personal health data and images, to the study Investigator, Sponsor, and regulatory
   authorities.

   3. Present for surveillance imaging due to increased risk for HCC, including either:

      1. Diagnosis of cirrhosis based on at least one of the following:

         - Histology from a liver biopsy.

         - Ultrasound, CT, or MRI showing a cirrhotic liver combined with portal
         hypertension (as evidenced by the presence of intra-abdominal varices, or
         recanalized umbilical vein, or ascites or splenomegaly or thrombocytopenia
         [defined as Platelet count < 150,000]). The imaging results must have been
         obtained within 5 years of study enrollment.

         - Liver stiffness ≥4.71 kilopascal (kPa) by Magnetic Resonance (MR)
         elastography or ≥12.1 kPa by vibration controlled transient elastography.

         - Presence of varices on endoscopy or imaging and presence of a chronic liver
         disease. OR

      2. Non-cirrhotic subjects with chronic Hepatitis B Virus (HBV) infection (Hepatitis
      B surface antigen present for >6 months)

Exclusion Criteria:

   1. Known cancer diagnosis (including active malignancy) within the past 5 years except
   for nonmelanoma skin cancer.

   2. Chemotherapy and/or radiation therapy within 5 years prior to study enrollment.

   3. Child-Pugh class C liver function at the time of enrollment, except for those on the
   waiting list for transplant.

   4. Solid liver nodule >1 cm by ultrasound or elevated Alpha-fetoprotein (AFP) (>100
   ng/mL) in 12 months preceding the qualifying surveillance imaging visit without
   subsequent documentation of HCC negative or LIRADS 1 (Liver Imaging Reporting and Data
   System) by diagnostic CT/MRI.

   5. Females known to be pregnant at the time of enrollment.

   6. Illness that the Investigator believes poses a significant risk of mortality during
   the study period, including but not limited to

      1. Congestive heart failure with ejection fraction <50%

      2. Chronic lung disease requiring supplemental oxygen.

      3. History of recent stroke.

   7. Sustained virologic response (SVR) for Hepatitis C Virus (HCV) (undetectable HCV RNA
   12 to 24 weeks after completion of antiviral therapy) for >10 years prior to
   enrollment.

   8. Not able to have IV contrast for CT or MRI due to

      1. Allergy to IV contrast and unwilling or unable to receive IV contrast after
      pre-medication.

      2. Estimated glomerular filtration rate <35 mL/min and not on hemodialysis.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting