CClinicalTrials.gg
Status unknownNCT03138239Updated May 3, 2017

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

An interventional study of Ga-68-PSMA scan, and PET -CT F-18-FDG in Hepatocellular Carcinoma (HCC), sponsored by Tel-Aviv Sourasky Medical Center. Status unknown. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-05-03.

Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 120 Years
Sex
All
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Study 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.

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Conditions studied

  • Hepatocellular Carcinoma (HCC)

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03

In context

Liver Neoplasms

1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.

This study's planned enrollment of 16 is below the median of 47 across 968 interventional studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 16 patients diagnosed with HCC.

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (estimated)

Study arms

  • 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

Interventions

  • RadiationGa-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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: The duration of the entire study will last about one year.

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03138239
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
May 3, 2017
Start date
Jul 2, 2017 (estimated)
Primary completion
Jul 2, 2018 (estimated)
Completion
Jul 2, 2019 (estimated)
Last update
May 3, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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