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Study of [68Ga]Ga-PentixaFor PET-CT Imaging in Patients with Metastatic Triple-Negative Breast Cancer

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What is this trial about?

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

This study focuses on patients with triple-negative breast cancer that has spread to other parts of the body (metastatic). The study will use a new imaging substance called [68Ga]Ga-PentixaFor, which is given as an injection into a vein. This substance is used with special imaging tests called PET-CT scans to detect cancer cells in the body.

The purpose of this study is to compare how well this new imaging method can detect cancer spots compared to a standard imaging test that uses a different substance called [18F]FDG. The study will look at whether both types of scans find the same cancer spots and how they match up with each other. Patients will receive the new imaging substance as a single injection, and pictures of their body will be taken using special cameras.

During the study, doctors will monitor patients for 60 minutes after receiving the injection to check for any side effects. The total amount of the imaging substance used will not exceed 200 megabecquerels (a measure of radioactivity). The imaging will be done twice during the study: once at the beginning and again if the cancer shows signs of getting worse.

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
Initial scans and imaging
You will undergo an initial PET-CT scan using a substance called FDG, which helps detect cancer cells in your body.
This scan will identify measurable metastases (areas where cancer has spread) in your body.
Step 2
Pre-medication checks
Laboratory tests will be performed to confirm your organ function is adequate for the study medication.
Your vital signs will be checked before proceeding with the study medication.
Step 3
Study medication administration
You will receive an injection of [68Ga]Ga-PentixaFor through an intravenous line (into a vein).
Your vital signs will be monitored for 60 minutes after receiving the injection.
You should report any unusual physical signs that occur within 48 hours after receiving the injection.
Step 4
Follow-up imaging
A PET-CT scan using the study medication ([68Ga]Ga-PentixaFor) will be performed.
Regular CT scans will be conducted to monitor your condition.
If your disease shows progression, additional scans will be performed using both the initial FDG PET-CT and the study medication PET-CT.
Step 5
Optional procedures
If a biopsy of metastatic tissue is performed during screening or at disease progression, the tissue will be analyzed to compare with scan results.
Step 6
Safety monitoring
Your condition will be monitored throughout the study period.
Any side effects will be recorded using standardized criteria (CTC-NCI Common Toxicity Criteria, version 5.0).

Who can join the trial?

11 criteria

Must sign a written consent form before any study procedures begin
Must be at least 18 years old
Must have triple negative breast cancer confirmed by tissue examination, with the following characteristics: - Estrogen receptors less than 10% - Progesterone receptors less than 10% - HER2 protein not increased or multiplied
Must have breast cancer that has either spread to other parts of the body or returned after previous treatment, confirmed by special imaging scans
Must have good physical ability to perform daily activities (ECOG performance status less than 2, meaning able to carry out light activities)
Must have a negative pregnancy test before receiving the study medication
Must agree to use contraception for at least 3 months after receiving the study medication
Must have adequate organ function confirmed by laboratory tests
Must have a life expectancy of at least 3 months
Must have valid health insurance
Must be willing and able to follow the study protocol, including attending all scheduled visits and examinations

Who cannot join the trial?

11 criteria

Patients who have had any anti-cancer therapy within 21 days before starting the study imaging procedures
History of other types of cancer in the past 5 years (except successfully treated non-melanoma skin cancer or cervical cancer in situ)
Pregnant or breastfeeding women
Severe claustrophobia (fear of confined spaces) that would prevent lying still during imaging procedures
Any metal implants or devices that could interfere with imaging procedures
Known allergies to imaging contrast agents or radiopharmaceuticals (substances used during imaging)
Severe kidney or liver problems that could affect the processing of imaging agents
Unable to lie flat and still for approximately 30 minutes during imaging procedures
Participation in another clinical trial within 30 days before this study
Any medical condition that, in the opinion of the study doctor, makes participation unsafe
Unable to provide informed consent or follow study procedures

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Verified sites

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Verified
Institut de Cancérologie de l'Ouest
Saint-Herblain, France

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Investigated drugs

[68Ga]Ga-PentixaFor
is an imaging agent used in PET-CT scans. It helps doctors see specific types of cells in the body, particularly those that have certain proteins on their surface. This imaging agent is being tested to see how well it can detect cancer lesions in patients with metastatic triple negative breast cancer.
[18F]FDG
(fluorodeoxyglucose) is a commonly used imaging agent in PET-CT scans. It is similar to glucose (sugar) and helps doctors see areas in the body where cells are using more energy than normal, which often indicates the presence of cancer. This imaging agent is being used as a comparison to evaluate how well the new imaging agent works.

What is already known about the treatment

[68Ga]Ga-PentixaFor
A diagnostic radiopharmaceutical administered intravenously for PET/CT imaging, specifically designed to detect and visualize CXCR4 receptor expression in triple-negative breast cancer. This novel imaging agent consists of a gallium-68 radioisotope combined with a pentixafor molecule that specifically binds to CXCR4 receptors commonly expressed in cancer cells, allowing for precise tumor detection and staging. Currently undergoing clinical evaluation, this tracer represents an innovative approach in nuclear medicine imaging, offering potential advantages in the diagnosis and monitoring of metastatic breast cancer when compared to conventional FDG PET/CT scanning.
[18F]FDG
A widely established radioactive glucose analog used in PET/CT imaging, administered through intravenous injection for cancer detection and staging. Fluorodeoxyglucose (FDG) labeled with fluorine-18 is the most commonly used radiotracer in oncology, working by accumulating in cells with high glucose metabolism, particularly cancer cells. This diagnostic agent has been the gold standard in PET imaging for decades, helping clinicians detect, stage, and monitor various types of cancer, including breast cancer, by highlighting areas of abnormal metabolic activity in the body.

Investigated diseases

Triple-negative breast cancer - A type of breast cancer where cancer cells lack three common receptors: estrogen, progesterone, and HER2 protein. This cancer typically develops in breast tissue when cells begin to grow abnormally and divide more rapidly than healthy cells. It tends to be more common in women under age 40 and often presents as an aggressive form of breast cancer. The disease can spread from the breast to other parts of the body through the lymphatic system or bloodstream. This condition affects the breast tissue and can cause changes in breast appearance, texture, or size.