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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Radiation: Ga-68-PSMA scan, and PET -CT F-18-FDG

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 16 patients diagnosed with HCC.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 16 patients diagnosed with HCC; 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.

Radiation: Ga-68-PSMA scan, and PET -CT F-18-FDG; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The duration of the entire study will last about one year.

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): July 2, 2017
• Primary Completion (Anticipated): July 2, 2018
• Study Completion (Anticipated): July 2, 2019

Study Registration Dates

• First Submitted: April 30, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: TASMC-17-ES-0056-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No