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Study on 18F-FES PET/MRI for Patients with Luminal A and Lobular Breast Cancer to Improve Treatment Decisions

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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 two types of breast cancer: luminal A and ER-positive lobular breast cancer. The study will use a special imaging technique called FES PET/MRI to help tailor treatment for these breast cancer subtypes. FES PET/MRI is a combination of two imaging methods, PET and MRI, which helps in detecting cancerous areas in the body. The purpose of the study is to compare the effectiveness of FES PET/MRI with another imaging method, axillary ultrasound, in identifying cancer spread to the lymph nodes in the armpit area, known as the axilla.

Participants in the study will undergo imaging with FES PET/MRI and axillary ultrasound to see which method is better at detecting larger cancer deposits in the lymph nodes. The study aims to show that FES PET/MRI is more sensitive, meaning it can better identify cancerous lymph nodes compared to ultrasound. This could help doctors make more informed decisions about the need for surgery in patients with these types of breast cancer.

The trial will also look at other aspects of FES PET/MRI, such as its accuracy and how it compares to standard imaging techniques like mammography and ultrasound. Additionally, the study will explore the relationship between imaging results and a recurrence score, which predicts the likelihood of cancer returning. This information could be valuable in planning personalized treatment strategies for patients with luminal A and ER-positive lobular breast cancer.

The research process

The trial runs in 7 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 such as age, diagnosis, and health status.
Informed consent is required, ensuring understanding of the study's purpose and procedures.
Step 2
Initial assessment
An initial assessment is conducted to gather baseline health information.
This may include imaging tests such as FES PET/MRI and axillary ultrasound to evaluate the presence of cancer in lymph nodes.
Step 3
Imaging procedures
The FES PET/MRI is performed to detect cancerous lymph nodes. This imaging technique uses a special tracer to highlight areas of concern.
The axillary ultrasound is also conducted to compare its effectiveness with the FES PET/MRI.
Step 4
Surgery preparation
If surgery is planned, further imaging may be required to assist in surgical planning.
The results from the FES PET/MRI and ultrasound are used to guide surgical decisions.
Step 5
Surgery
Surgery is performed as the first treatment option for eligible patients.
The surgical procedure aims to remove cancerous tissue and affected lymph nodes.
Step 6
Post-surgery evaluation
After surgery, further evaluation is conducted to assess the effectiveness of the treatment.
This may include additional imaging and pathology tests to confirm the removal of cancerous tissue.
Step 7
Follow-up
Regular follow-up appointments are scheduled to monitor health and detect any recurrence of cancer.
These appointments may include imaging tests and clinical evaluations.

Who can join the trial?

7 criteria

Female patients aged 18 years or older.
Able to sign the informed consent on their own.
Patients diagnosed with **LumA** or **ER-positive Lob** breast cancer. **LumA** and **ER-positive Lob** are specific types of breast cancer.
Candidates for surgery as the first treatment, regardless of the status of lymph nodes in the armpit area.
Normal liver and kidney function.
Women who can have children must agree to use highly effective birth control methods during the trial. This includes options like an intrauterine device without hormones, sexual abstinence, or if the partner has had a vasectomy. Other methods include using a condom, cap, diaphragm, or sponge with spermicide.
For the translational group: Patients with large tumors (more than 2 cm) that show differences in imaging or final pathology. This means the tumor may look different in various parts or have different types of cells.

Who cannot join the trial?

4 criteria

Patients who do not have **primary or advanced breast cancer** of the LumA or ER+ Lobular subtypes cannot participate.
Patients who are not candidates for **axillary surgery** for primary breast cancer cannot participate. Axillary surgery is a procedure to remove lymph nodes from the armpit area.
Patients who are not female cannot participate.
Patients who are considered part of a **vulnerable population** cannot participate. A vulnerable population includes groups who may have limited ability to protect their own interests.

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Verified sites

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Ospedale San Raffaele S.r.l.
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Milan, Italy

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Investigated drugs

18F-FES is a special imaging agent used in PET/MRI scans. It helps doctors see certain types of breast cancer more clearly. In this trial, it is used to check if it can better detect cancer spread in the lymph nodes compared to traditional methods.

What is already known about the treatment

18F-FES – This medication is administered as an injection and is used in combination with PET/MRI imaging. It is currently being studied in clinical trials to assess its effectiveness in detecting certain types of breast cancer, specifically luminal A and ER+ lobular subtypes. The main therapeutic indication is to improve the accuracy of cancer staging by identifying metastatic lymph nodes. At the molecular level, 18F-FES binds to estrogen receptors, allowing for visualization of estrogen receptor-positive tumors during imaging. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Breast Cancer – Breast cancer is a disease where cells in the breast grow uncontrollably. It can begin in different parts of the breast, most commonly in the ducts or lobules. The disease is categorized into various subtypes, such as Luminal A (LumA) and Estrogen Receptor Positive (ER+) Lobular subtypes, based on specific characteristics of the cancer cells. As the disease progresses, it may spread to nearby lymph nodes or other parts of the body. The growth and spread of cancer cells can lead to the formation of tumors, which may be detected through imaging techniques. Understanding the subtype of breast cancer is crucial for determining the appropriate management approach.