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Study on F-18 PSMA-11 PET Imaging for Liver Cancer in Patients to Evaluate Survival

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Hepatocellular Carcinoma, a type of liver cancer. The study will use a special imaging technique called F-18 PSMA-11 PET/CT to help in the imaging and staging of this cancer. The purpose of the study is to determine how accurately this imaging method can identify and stage liver cancer compared to other imaging techniques like F-18 FDG PET/CT and F-18 Choline PET/CT.

Participants in the study will receive an injection of a solution containing [18F]PSMA-11, which is a chemical substance known as Gozetotide ALF-18. This substance helps to highlight cancer cells during the imaging process. The study will involve taking images of the liver 60 to 90 minutes after the injection to see how well the cancer can be detected and staged. The study will also look at how long patients live and how long they remain free from cancer progression after the imaging.

The trial will follow participants for up to two years to gather information on survival rates and the effectiveness of the imaging technique. The study aims to provide valuable insights into the use of F-18 PSMA-11 PET/CT for better diagnosis and management of liver cancer, potentially improving outcomes for patients with this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, mental capacity to consent, and specific medical conditions related to hepatocellular carcinoma (HCC).
Eligibility requires either a new diagnosis of HCC with high risk of metastases or a known diagnosis requiring restaging.
Step 2
Pre-study imaging
Participants must have undergone or have plans to undergo F-18 FDG PET/CT and F-18 Choline PET/CT scans within four weeks prior to the study. These scans are part of the diagnostic or staging process for HCC.
Step 3
Administration of F-18 PSMA-11
The study involves the administration of [18F]PSMA-11, a solution for injection, given intravenously. This is used for imaging purposes.
The injection is followed by a waiting period of 60-90 minutes before imaging to allow the substance to circulate and highlight areas of interest.
Step 4
Imaging procedure
After the waiting period, a PET/CT scan is performed to assess the presence and extent of HCC lesions.
The scan evaluates the tumor-to-background ratio and standard uptake value (SUV) parameters for detected lesions.
Step 5
Follow-up and monitoring
Participants are monitored for overall survival (OS) and progression-free survival (PFS) over a two-year follow-up period.
The study also compares the detection of metastatic HCC using F-18 PSMA-11 PET/CT against other imaging methods.

Who can join the trial?

5 criteria

Must be **willing** and **mentally capable** to provide written informed consent. This means you agree to participate and understand what the study involves.
Must be **18 years of age or older**.
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Must have one of the following **clinical scenarios**:
- New diagnosis of **hepatocellular carcinoma (HCC)**, which is a type of liver cancer, confirmed by a biopsy (a small sample of tissue taken for testing) or imaging tests. The cancer should have a high risk of spreading, shown by either invasion into the portal vein (a major blood vessel in the liver) or a primary tumor larger than 5 centimeters.
- Known diagnosis of HCC that needs restaging. This could be due to unexplained high levels of **AFP tumor markers** (proteins that can indicate cancer), known spread of cancer, starting immunotherapy (a treatment that helps your immune system fight cancer), or being on the waiting list for a liver transplant.
- Must have either planned or recently undergone (within the past 4 weeks) both **F-18 FDG PET/CT** and **F-18 Choline PET/CT** scans. These are imaging tests used to help diagnose or stage the cancer.

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Universitair Ziekenhuis Gent
Gent, Belgium

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Investigated drugs

F-18 PSMA-11
is a radioactive tracer used in PET/CT scans to help visualize and stage hepatocellular carcinoma, a type of liver cancer. It binds to specific proteins on cancer cells, allowing doctors to see the cancer more clearly on the scan.
F-18 FDG
is another radioactive tracer used in PET/CT scans. It is commonly used to detect cancer because it highlights areas of high glucose metabolism, which is often increased in cancer cells.
F-18 Choline
is a tracer used in PET/CT imaging to help detect certain types of cancer, including liver cancer. It is absorbed by cells that are rapidly dividing, such as cancer cells, making them visible on the scan.

Gozetotide Alf-18

What is already known about the treatment

F-18 PSMA-11 – This medication is administered as an intravenous injection and is used in PET/CT imaging. It is currently being studied for its effectiveness in diagnosing and staging hepatocellular carcinoma, a type of liver cancer. The main therapeutic indication is to improve the accuracy of cancer staging, which can help in planning treatment strategies. At the molecular level, F-18 PSMA-11 binds to the prostate-specific membrane antigen (PSMA), which is often overexpressed in certain cancer cells, allowing for better imaging contrast. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Hepatocellular carcinoma – This is a type of liver cancer that originates in the hepatocytes, the main type of liver cell. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. The disease typically progresses by forming a single tumor or multiple small nodules within the liver. As it advances, it can invade blood vessels and spread to other parts of the body. Symptoms may include abdominal pain, weight loss, and jaundice, but they often appear only in later stages. The progression of the disease can vary, with some tumors growing slowly and others more rapidly.