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The Potential Role of Ga-68-PSMA in Staging, Restaging and Monitoring Response in Primary Liver Cancer: Comparison With F-18-FDG

Primary Purpose

Hepatocellular Carcinoma (HCC)

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ga-68-PSMA scan, and PET -CT F-18-FDG
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma (HCC)

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 16 patients diagnosed with HCC.

Exclusion Criteria:

  • Minors under the age of 18
  • Pregnant women
  • People without primary liver cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    16 patients diagnosed with HCC

    Arm Description

    12 patients will be tested at the stage of diagnosis (staging) 4 patients who have tested at staging, will be tested again after treatment. 4 patients with treatment failure or recurrence.

    Outcomes

    Primary Outcome Measures

    Measure the absorption of PET-CT F-18-FDG and of PET -CT Ga-68-PSMA
    Measuring it in patients with primary liver cancer at staging, restaging and monitoring response.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 30, 2017
    Last Updated
    May 2, 2017
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03138239
    Brief Title
    The Potential Role of Ga-68-PSMA in Staging, Restaging and Monitoring Response in Primary Liver Cancer: Comparison With F-18-FDG
    Official Title
    The Potential Role of Ga-68-PSMA in Staging, Restaging and Monitoring Response in Primary Liver Cancer: Comparison With F-18-FDG
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2, 2017 (Anticipated)
    Primary Completion Date
    July 2, 2018 (Anticipated)
    Study Completion Date
    July 2, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hepatocellular carcinoma (HCC) is the fifth most common cancer and the second leading cause of cancer-related deaths in the world. Hepatitis C virus (HCV) is the most common underlying cause of cirrhosis and HCC in the western world. The staging of the disease is done by combining blood tests and imaging tests. Ultrasound scanning, computed tomograph (CT) and magnetic resonance imaging (MRI) scans are methods based on identifying or significant change in the liver. Those changes are sometimes difficult to identify, especially when there are changes in liver structure resulting from disease, such as cirrhosis of the liver. In many cases it is also difficult to detect secondary scattering in anatomical tests, such as identifying a disease in normal size lymph nodes or early skeletal dissociation. Functional imaging is not based on structural changes, but on the ability to detect changes in the function and properties of the tissue, such as a change in the cell's metabolic consumption or the presence of proteins that characterize the tumor tissue.PET scans can show tumor cell activity (the cancer cells are more aggressive, get more sugar and therefore see more absorption in PET), detect small tumors and metastases outside the liver (because they do a whole body test). To complete this test, a CT scan is also performed on the same device (PET-CT scanner). There is a new material called prostate-specific mRNA that is marked with gallium isotope (Ga-68-PSMA). It is the substance that is absorbed into the cells of the blood vessels of the tumor. The Ga-68-PSMA is now widely used in the diagnosis of prostate cancer. The new researches also found the possibility of using Ga-68-PSMA in primary liver cancer in patients because of the over-expression of the antigen in the blood vessels. Therefore, the tests with Ga-68-PSMA and F-18-FDG will complement each other and will give a complete picture of the extent of the disease. Each patient has individual characteristics of the tumor, and according to the results it will be possible to adapt the test to the patient with the appropriate material for the disease and this will be effective for the decision to treat and follow up. At the end of the study it will be possible to offer the study participant the appropriate functional imaging test.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatocellular Carcinoma (HCC)

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    16 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    16 patients diagnosed with HCC
    Arm Type
    Experimental
    Arm Description
    12 patients will be tested at the stage of diagnosis (staging) 4 patients who have tested at staging, will be tested again after treatment. 4 patients with treatment failure or recurrence.
    Intervention Type
    Radiation
    Intervention Name(s)
    Ga-68-PSMA scan, and PET -CT F-18-FDG
    Intervention Description
    The patient will do tow mappings on two different days. It should be noted that there is no importance to the order between the two tests on the condition that they be performed within 7-10 days of each other. Both tests will be performed with the Discovery 690 camera, which is located at the Nuclear Medicine Institute. First test PET-CT with F-18-FDG PET-CT second test with Ga-68-PSMA
    Primary Outcome Measure Information:
    Title
    Measure the absorption of PET-CT F-18-FDG and of PET -CT Ga-68-PSMA
    Description
    Measuring it in patients with primary liver cancer at staging, restaging and monitoring response.
    Time Frame
    The duration of the entire study will last about one year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 16 patients diagnosed with HCC. Exclusion Criteria: Minors under the age of 18 Pregnant women People without primary liver cancer

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Potential Role of Ga-68-PSMA in Staging, Restaging and Monitoring Response in Primary Liver Cancer: Comparison With F-18-FDG

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