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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 study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Sydvestjysk Sygehus Esbjerg Denmark

Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
01.03.2024

Trial locations

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.

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.

Trial ID:
2023-506550-20-00
Trial Phase:
Therapeutic use (Phase IV)

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