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
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma (HCC)
Eligibility Criteria
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
NCT ID
NCT03138239
First Posted
April 30, 2017
Last Updated
May 2, 2017
Sponsor
Tel-Aviv Sourasky Medical Center
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
We'll reach out to this number within 24 hrs