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Study on Monitoring Metastatic Breast Cancer Response Using Fludeoxyglucose (18F) PET/CT for Patients with Metastatic Breast Cancer

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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 metastatic breast cancer, which is a type of breast cancer that has spread to other parts of the body. The study will compare two different methods of monitoring the disease's response to treatment. One method uses a special imaging technique called FDG-PET/CT, which involves a substance known as Fludeoxyglucose (18F). This substance helps to highlight cancer cells during the scan. The other method uses a more traditional imaging technique called CT or computed tomography. The purpose of the study is to determine if the FDG-PET/CT method is better at monitoring the disease compared to the conventional CT method.

Participants in the study will undergo regular scans using either the FDG-PET/CT or the CT method to monitor how their cancer is responding to treatment. The study aims to see if using FDG-PET/CT can improve overall survival for patients with metastatic breast cancer. The study will also look at other factors such as quality of life, the time and exposure to treatment, cost-effectiveness, and any side effects that may occur.

This trial is a pilot study, which means it is a smaller, preliminary study that will help researchers plan a larger, more definitive study in the future. The results from this pilot study will provide important information about the potential benefits of using FDG-PET/CT for monitoring metastatic breast cancer and may lead to improved treatment strategies for patients in the future.

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 criteria such as age, diagnosis of metastatic breast cancer, and ability to understand Danish.
Informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment is conducted to establish a baseline for monitoring. This includes a biopsy verification of the primary tumor and any disseminated disease.
Step 3
Treatment monitoring
The study involves monitoring the response to treatment using two different imaging techniques: FDG-PET/CT and conventional CT scans.
The primary goal is to determine which method is more effective in monitoring the response to treatment in terms of overall survival.
Step 4
Administration of fludeoxyglucose (18f)
The substance fludeoxyglucose (18f) is administered intravenously. This is used in the FDG-PET/CT scans to help visualize the cancerous tissues.
Step 5
Ongoing assessments
Regular scans are conducted to monitor the response to treatment. These assessments are based on standardized criteria adapted for each imaging method.
The study aims to evaluate overall survival, quality of life, time and exposure to treatment, cost-effectiveness, and the occurrence of any adverse events.
Step 6
Completion of study
The study is estimated to conclude by February 28, 2025. At this point, all data will be analyzed to determine the effectiveness of the imaging techniques in monitoring treatment response.

Who can join the trial?

6 criteria

Women and men who are **18 years or older** can participate.
Participants must have a **diagnosis of metastatic breast cancer**. This means the cancer has spread to other parts of the body. The diagnosis should be confirmed by a **biopsy**, which is a small sample of tissue taken from the body to check for cancer cells.
Participants should be eligible for **first-line systemic treatment**, which is the initial treatment given to manage cancer throughout the body.
Participants should be eligible for **continuous treatment monitoring by scans**. This means they can have regular imaging tests to check how the treatment is working.
Participants must have **signed informed consent**, which means they agree to take part in the study after being informed about what it involves.
Participants need to have the **ability to read and understand the Danish language**.

Who cannot join the trial?

3 criteria

Patients who do not have metastatic breast cancer cannot participate. This means the cancer has spread from the breast to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population cannot participate. This typically includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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

Odense University Hospital
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Odense, Denmark
Sygehus Lillebaelt Vejle Sygehus
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Vejle, Denmark

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Investigated drugs

FDG-PET/CT
is an imaging technique used in this trial to monitor the response of metastatic breast cancer to treatment. It involves using a special type of scan that combines positron emission tomography (PET) with computed tomography (CT). This method helps doctors see how the cancer is responding to treatment by showing changes in the activity of cancer cells.
Conventional CT
is another imaging method used in the trial to monitor the response of metastatic breast cancer. It uses X-rays to create detailed pictures of the inside of the body. This technique helps doctors assess the size and shape of tumors to determine how well the treatment is working.

Fludeoxyglucose (18F)

What is already known about the treatment

FDG-PET/CT – This is a diagnostic imaging method rather than a medication, used to monitor the response of metastatic breast cancer to treatment. It involves the administration of a radioactive glucose compound, which is injected into the bloodstream. The current status in medical literature highlights its potential superiority over conventional CT scans for assessing treatment response. The main therapeutic indication is for evaluating the effectiveness of cancer therapies in patients with metastatic breast cancer. At the molecular level, FDG-PET/CT works by detecting areas of high glucose metabolism, which are often indicative of cancerous activity. It is classified under diagnostic imaging techniques rather than pharmacological agents.

Investigated diseases

Metastatic breast cancer – This 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 is considered an advanced stage of breast cancer, often referred to as stage IV. The disease progresses as cancer cells travel through the bloodstream or lymphatic system to form new tumors in other organs. Symptoms can vary depending on where the cancer has spread, but may include bone pain, difficulty breathing, or neurological symptoms. The progression of metastatic breast cancer can be unpredictable, with periods of stability followed by periods of growth. The focus is often on managing symptoms and maintaining quality of life.