AuthorisedTherapeutic exploratory (Phase II)Interventional

18F-FES PET/MRI for tailoring treatment of luminal A and lobular breast cancer: a phase II trial evaluating the performance of FES PET/MRI in axillary staging

This research study is for women aged 18 and over who have been diagnosed with particular types of breast cancer known as Luminal A or ER+ Lobular breast cancer. The main goal is to test a new imaging scan called FES PET/MRI. We want to see if this special scan is more effective than the usual ultrasound scan at detecting if breast cancer has spread to the lymph nodes in the armpit. Finding out if cancer has spread early can help doctors plan the best treatment. This study is in Phase II, which means it's an early but important step in checking how well this new scan works.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universita' Vita-salute S. Raffaele

Enrolment target

221

Start

04 Jul 2024

Primary or advanced breast cancer LumA or ER+ Lobular subtypes.

What is this study about?

This study is about finding the best ways to check for breast cancer spread, especially in the lymph nodes under the armpit. When breast cancer spreads, it often goes to these lymph nodes first. Knowing if the cancer has spread helps doctors decide on the most suitable treatment for you. This particular study focuses on two specific types of breast cancer: Luminal A and ER+ Lobular breast cancer.

We are looking at a new scanning method called FES PET/MRI. This combines two powerful imaging techniques (PET and MRI) to get detailed pictures of your body. The study aims to compare how well this new FES PET/MRI scan finds cancer in the armpit lymph nodes compared to the standard ultrasound scan that is currently used. We believe FES PET/MRI might be better at detecting these cancer cells, especially larger ones.

By finding cancer in the lymph nodes more accurately, doctors can tailor your treatment plan more effectively, which could lead to better outcomes. This research is a 'Phase II' study, which means we are carefully evaluating the scan's performance and gathering important information to see if it's a promising option for future use.

Key takeaways

Tests a new scan (FES PET/MRI) for certain breast cancers.
Aims to find cancer in armpit lymph nodes more accurately.
Could help doctors tailor treatment better.
For women with Luminal A or ER+ Lobular breast cancer.
No new medications involved, just an extra scan.

Who may be eligible?

This study is looking for women who are at least 18 years old.

You might be able to join if you have been diagnosed with certain types of breast cancer. Specifically, this includes 'Luminal A' or 'ER+ Lobular' breast cancer, whether it's newly diagnosed or has come back.

It's important to talk to your doctor about your specific breast cancer type to see if this study could be an option for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you 18 years old or older?
Have you been diagnosed with Luminal A breast cancer?
Have you been diagnosed with ER+ Lobular breast cancer?
Are you able to undergo PET and MRI scans?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve having the new FES PET/MRI scan in addition to the standard scans and tests you would normally have as part of your cancer care. The study aims to compare the results from the new scan with the standard ultrasound to see which is better at finding cancer in the armpit lymph nodes. You would also have your medical records reviewed as part of the study to help compare the scans with other information about your cancer, such as how it might come back.

The number of visits and the full duration of your participation will depend on your individual treatment plan and how long it takes to collect the necessary scan results and follow-up information. The study will not involve taking any new medications, but rather focuses on the performance of a new diagnostic imaging technique. You will continue to receive your usual cancer treatment as recommended by your doctors.

Potential risks and benefits

There are no direct medical benefits from taking part in this study, but the information gained could help improve how breast cancer is treated in the future, which might benefit other patients. The FES PET/MRI scan involves a small amount of radiation, similar to other commonly used scans, and there are very low risks associated with the dye used in the MRI. You have the right to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy

Common questions

What is FES PET/MRI?

It's a special type of scan that combines two powerful imaging techniques (PET and MRI) to get very detailed pictures inside your body, helping doctors look for cancer cells.

Why is this study important?

It aims to find a better way to check if breast cancer has spread to the armpit lymph nodes. This information helps doctors choose the best treatment for you.

Will I have to take new medicines?

No, this study is about evaluating a new scan, not new medicines. You will continue with your usual cancer treatment as planned by your doctors.

Who can join this study?

Women aged 18 or older with specific types of breast cancer, called Luminal A or ER+ Lobular breast cancer, might be eligible.

What if I change my mind about participating?

You are free to leave the study at any time, and it won't affect the care you receive from your medical team.