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Study on the Diagnostic Performance of 68Ga-ABS011 PET/CT for Patients with Metastatic Breast Cancer

Verified siteInvestigationalNo placebo

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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 a type of breast cancer known as metastatic breast cancer (mBC). Specifically, it looks at different subtypes of this cancer, including hormone receptor-positive/HER2-negative, triple-negative, and HER2-positive mBC. The study uses a special diagnostic tool called 68Ga-ABS011, which is a solution for injection. This tool is used in a type of imaging called Positron Emission Tomography and Computed Tomography (PET/CT) to help doctors see how the cancer is behaving in the body.

The purpose of the study is to evaluate how well the 68Ga-ABS011 PET/CT works compared to the standard tests currently used to check the status of a protein called HER2 in breast cancer. During the study, participants will receive an injection of 68Ga-ABS011, and then undergo a PET/CT scan. This will help doctors determine if the new method provides better or additional information compared to the usual tests. The study will also monitor any side effects that participants might experience from the injection or the scan.

Participants in the study will have several visits over a period of time, during which they will undergo the PET/CT scan and possibly a biopsy, which is a procedure to take a small sample of tissue for testing. The study aims to see if the new imaging method can help guide treatment decisions and improve the management of metastatic breast cancer. The trial is expected to continue until the end of 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of breast cancer, and willingness to undergo certain procedures.
Informed consent is required, ensuring understanding of the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment involves a comprehensive evaluation of the cancer status using imaging techniques such as PET/CT scans.
A biopsy may be performed to obtain a sample of the tumor for further analysis.
Step 3
Administration of 68Ga-ABS011
The medication 68Ga-ABS011 is administered as a solution for injection through an intravenous bolus injection or infusion.
This step is crucial for evaluating the diagnostic performance of the imaging technique.
Step 4
Imaging and evaluation
Following the administration of the medication, a PET/CT scan is conducted to assess the presence and extent of cancer.
The results are compared to standard tests to evaluate the accuracy of the new imaging method.
Step 5
Follow-up and monitoring
Regular follow-up visits are scheduled to monitor any adverse events and the overall health status.
The impact of the imaging results on treatment decisions is assessed, potentially influencing future management of the cancer.
Step 6
Completion of study participation
Participation in the study concludes after all necessary evaluations and follow-ups are completed.
The study aims to finish by the end of 2025, with recruitment starting in August 2024.

Who can join the trial?

8 criteria

Adult patients who are 18 years or older, both male and female.
Patients with confirmed metastatic Breast Cancer (mBC), whether newly diagnosed or previously treated.
Patients with specific types of mBC: hormone receptor positive/HER2 negative, triple-negative, or HER2 positive, who might be eligible for certain HER2 targeted treatments.
Patients must have at least one cancerous area outside the liver that can be biopsied and is visible on a special scan called FDG PET/ceCT, and it should be at least 15 mm in size.
Patients must be willing to have at least one tumor biopsy.
Male patients who can father children and female patients who can become pregnant must agree to use effective birth control methods during the study.
Patients should have an ECOG performance status of 0 to 2, which is a scale that measures how well they can perform daily activities.
Patients must be able and willing to provide written consent to participate in the study.

Who cannot join the trial?

4 criteria

Patients who do not have **metastatic breast cancer**. This means the cancer has spread to other parts of the body.
Patients who are not within the specified age range for the study.
Patients who are not able to undergo the specific tests required by the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Vrije Universiteit Brussel
Verified
Jette, Belgium

Trial locations

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Investigated drugs

68Ga-ABS011
is a special imaging agent used in PET/CT scans to help doctors see how breast cancer has spread in the body. It targets a specific protein called HER2, which is often found in higher amounts in some breast cancer cells. This helps in diagnosing and understanding the extent of the cancer more accurately.
IHC (Immunohistochemistry)
is a standard test used to check for the presence of HER2 protein in breast cancer tissue. It helps doctors determine the best treatment options based on the HER2 status of the cancer.
ISH (In Situ Hybridization)
is another standard test that looks for HER2 gene amplification in breast cancer cells. It is often used alongside IHC to confirm the HER2 status and guide treatment decisions.

68Ga-Nota-Abscint-Her2

What is already known about the treatment

68Ga-ABS011 – This medication is administered through an injection and is used in a PET/CT scan to help diagnose metastatic breast cancer. It is currently being studied in clinical trials to assess its effectiveness in identifying HER2 status in breast cancer patients. The main therapeutic indication is for patients with hormone receptor-positive, HER2-negative, triple-negative, or HER2-positive metastatic breast cancer. At the molecular level, 68Ga-ABS011 targets the HER2 protein, which is often overexpressed in certain types of breast cancer, allowing for precise imaging. It falls under the pharmacological classification of radiopharmaceuticals used in diagnostic imaging.

Investigated diseases

Metastatic Breast Cancer – Metastatic breast cancer is a type of breast cancer that has spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. It can be classified based on the presence or absence of certain receptors, such as hormone receptors and HER2. Hormone receptor-positive breast cancer grows in response to hormones like estrogen or progesterone. HER2-positive breast cancer has higher levels of a protein called HER2, which promotes the growth of cancer cells. Triple-negative breast cancer lacks estrogen, progesterone, and HER2 receptors, making it more challenging to treat. The progression of metastatic breast cancer involves the spread of cancer cells through the bloodstream or lymphatic system to distant organs, where they form new tumors.