Study Comparing FDG-PET/CT and CT for Monitoring Treatment Response in Patients with Metastatic Breast Cancer Using Fludeoxyglucose (18F)

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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 how well the cancer is responding to treatment. One method uses a special type of scan called FDG-PET/CT, which involves a small amount of radioactive sugar to help show cancer activity in the body. The other method uses a more traditional scan known as computed tomography (CT), which takes detailed pictures of the inside of the body.

The purpose of the study is to find out if using FDG-PET/CT is better than using CT for checking how the cancer is responding to treatment, with the hope of improving overall survival for patients. Participants in the study will be randomly assigned to have their cancer monitored with either FDG-PET/CT or CT. The study will follow participants over time to see which method provides better information about the cancer’s response to treatment.

Throughout the study, researchers will also look at other important factors, such as the quality of life of the participants, the time they spend on cancer treatment, and the cost-effectiveness of the monitoring methods. The study aims to provide valuable insights that could help improve the care and outcomes for people with metastatic breast cancer.

1 joining the study

Upon joining the study, you will be required to sign an informed consent form. This document confirms your understanding of the study and your willingness to participate.

You must meet certain criteria, such as being 18 years or older, having a diagnosis of metastatic breast cancer, and being eligible for first-line systemic treatment and continuous monitoring by scans.

2 initial assessment

An initial assessment will be conducted to gather baseline information about your health and the status of your cancer. This may include physical examinations, blood tests, and imaging scans.

3 randomization

You will be randomly assigned to one of two groups: one group will undergo monitoring with FDG-PET/CT scans, and the other group will undergo monitoring with conventional CT scans.

4 treatment and monitoring

You will receive the standard treatment for metastatic breast cancer, which may include medications and therapies as determined by your healthcare provider.

Regular monitoring will be conducted using the assigned imaging method to evaluate your response to treatment. The frequency and duration of these scans will be determined by the study protocol.

5 follow-up assessments

Throughout the study, follow-up assessments will be conducted to monitor your overall health, quality of life, and any side effects from the treatment.

These assessments may include questionnaires, interviews, and additional medical tests.

6 completion of the study

The study is expected to continue until December 31, 2029. Upon completion, a final assessment will be conducted to gather data on your overall survival and quality of life.

Results from the study will contribute to understanding the effectiveness of FDG-PET/CT versus conventional CT in monitoring metastatic breast cancer.

Who Can Join the Study?

Women and men aged 18 years or older.
Diagnosis of distant relapsed metastatic breast cancer (MBC) confirmed by a biopsy, which is a small sample of tissue taken from the body to check for cancer cells.
For patients with de novo breast cancer (newly diagnosed), a biopsy of the primary tumor and imaging tests showing distant metastasis are required.
Eligible for first-line systemic treatment, which is the initial treatment given for cancer that affects the whole body.
Eligible for continuous treatment monitoring by scans, meaning regular imaging tests to check how the treatment is working.
Must have signed informed consent, which means agreeing to participate in the study after being fully informed about it.
Must be able to read and understand the language required for the study in their country: Danish in Denmark, Italian or English in Italy, and German or English in Germany.

Who Cannot Join the Study?

Patients who do not have metastatic breast cancer cannot participate. Metastatic means the cancer has spread to other parts of the body.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy
Sydvestjysk Sygehus	Esbjerg	Denmark

Other Sites

Site Name	City	Country
Odense University Hospital	Odense	Denmark
Sygehus Lillebaelt Vejle Sygehus	Vejle	Denmark
Aalborg University Hospital	Aalborg	Denmark
Rigshospitalet	Copenhagen	Denmark
Sygehus Soenderjylland Soenderborg	Aabenraa	Denmark
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Roskilde University	Roskilde	Denmark
Antahv Ujaydpavxt Hpvetlrb	Aarhus	Denmark
Aqaxvbp Usonw Snzkgnfyo Lnjsvy Dx Bbdptcq	Bologna	Italy

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.10.2024
Germany	Not yet recruiting	01.10.2024
Italy	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Fludeoxyglucose (18F)

FDG-PET/CT is a type of imaging test that helps doctors see how your body is functioning. It uses a small amount of radioactive sugar to look for cancer cells in your body. This test is used in the trial to monitor how well the treatment is working for patients with metastatic breast cancer. It helps doctors see if the cancer is shrinking, staying the same, or growing.

CT, or computed tomography, is another type of imaging test that creates detailed pictures of the inside of your body. In this trial, CT scans are used to monitor the response of metastatic breast cancer to treatment. It helps doctors assess changes in the size of the cancer and determine how well the treatment is working.

Metastatic breast cancer – Metastatic breast cancer is a stage of breast cancer where the cancer cells have spread beyond the breast to other parts of the body, such as the bones, liver, lungs, or brain. This spread occurs when cancer cells break away from the original tumor and travel through the bloodstream or lymphatic system. The disease progresses as these cancer cells establish new tumors in other organs, disrupting their normal function. Symptoms can vary depending on the organs affected but may include bone pain, difficulty breathing, or neurological symptoms. The progression of metastatic breast cancer can be unpredictable, with periods of stability and periods of rapid growth. The disease is considered chronic, requiring ongoing management to control symptoms and slow progression.

Trial ID:

2023-508591-11-00

Protocol code:

2023-508591-11-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing FDG-PET/CT and CT for Monitoring Treatment Response in Patients with Metastatic Breast Cancer Using Fludeoxyglucose (18F)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?