RecruitingOBSERVATIONAL

Interest of PET-MRI in the Evaluation of the Response After Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

This study is investigating a new way to check how well treatment is working for people with advanced rectal cancer. Doctors usually use MRI scans to see the cancer and how it responds to treatment. This study is using a special type of scan called a PET-MRI, which combines two powerful scanning techniques. The goal is to see if these PET-MRI scans can predict early on if the cancer will respond well to chemotherapy and radiotherapy. If successful, this could help doctors understand sooner which treatments are best for each patient, potentially improving their care. It's a pilot study, meaning it's one of the first times this approach is being tested on a larger group of patients.

At a glance

Status

Recruiting

Sponsor

Centre Paul Strauss

Enrolment target

Start

19 May 2023

Estimated completion

18 Sep 2026

Rectal Cancer

What is this study about?

This study focuses on a type of cancer called locally advanced rectal adenocarcinoma, which is a cancer that has grown into the wall of the rectum or nearby tissues but hasn't spread to distant parts of the body. When someone has this type of cancer, they usually go through a two-step treatment process. First, they have medical treatments like chemotherapy (medicine to kill cancer cells) and radiotherapy (using radiation to kill cancer cells). After a break of several weeks, they then have surgery to remove the cancer.

Doctors currently use MRI scans to look at the cancer before treatment and to see how well it's responded to the initial chemotherapy and radiotherapy before surgery. While MRI is very helpful, it sometimes can't give a complete picture of how the cancer is truly reacting to the drugs and radiation. This is where a newer type of scan called 'PET-MRI' comes in. PET-MRI combines the detailed images from an MRI scan with information from a PET scan, which shows how active the cancer cells are using a special sugar injection.

Researchers believe that PET-MRI might be even better than a standard MRI at showing exactly how much the cancer has shrunk or changed after the first treatments. The main aim of this study is to find out if using PET-MRI scans during these initial treatments can help doctors predict much earlier if the cancer is responding well. If they can predict this early, it might help them adjust treatments if needed, potentially leading to better outcomes for patients. This study will involve 50 patients, making it the largest of its kind to explore this idea for rectal cancer.

Key takeaways

This study uses advanced PET-MRI scans for rectal cancer.
It aims to predict early how well treatments are working.
Could help doctors tailor treatment plans sooner.
Combines detailed MRI images with metabolic activity from PET.
Involves extra scans during your standard cancer care.

Who may be eligible?

To be able to join this study, you would generally need to have rectal cancer that has been confirmed by a doctor, and it should be locally advanced but not spread to other parts of the body. Your doctor would have already decided that you will have chemotherapy followed by radiotherapy as part of your treatment plan, and your cancer must be considered treatable with surgery after these initial treatments. You also need to be generally well enough to take part, with good overall health and no serious heart, liver, or blood problems that could make the treatment unsafe.

There are also some reasons why you might not be able to join. For example, if you have uncontrolled diabetes, or if you've already had radiotherapy to your pelvic area. Other reasons include having certain other serious medical conditions like uncontrolled infections, or if you have a history of certain bowel diseases or severe heart problems. You also can't be pregnant or breastfeeding, or taking part in another study for a new treatment. Finally, you must be able to understand and agree to take part in the study.

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.

Do I have locally advanced rectal cancer?
Am I already planning to have chemotherapy and radiotherapy before surgery?
Do I have any other major health conditions like uncontrolled diabetes or severe heart problems?
Am I pregnant or breastfeeding?
Have I had radiotherapy to my pelvis before?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive your standard chemotherapy and radiotherapy for rectal cancer as planned by your doctors. In addition to your usual scans, you will have several extra PET-MRI scans during your treatment. One of these will be before you start treatment, and another will be partway through your chemotherapy, before your fourth cycle or before your radiotherapy starts. There might be other scans performed as well, to help understand how the cancer is responding. The total duration of your participation in the study would cover the period of your pre-surgery treatments and the scans associated with them.

Potential risks and benefits

Taking part in this study could offer the potential benefit of closer monitoring of your cancer treatment through the advanced PET-MRI scans, which might give doctors more information about how your cancer is responding. However, it's also important to be aware of potential risks. Receiving extra PET-MRI scans means you will have additional exposures to a small amount of radiation, though this is carefully monitored. You will also need to have injections for the PET part of the scan. As with any medical procedure, there's a small risk of side effects from the imaging agents. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Institut de cancérologie Strasbourg Europe
Verified postcode
Strasbourg, France· Recruiting

Common questions

What is 'locally advanced rectal adenocarcinoma'?

It's a type of cancer that starts in the rectum, which is the last part of the large intestine. 'Locally advanced' means it has grown deeper into the bowel wall or nearby tissues but hasn't spread to other distant organs.

What is a PET-MRI scan?

It's a special type of scan that combines two powerful imaging techniques: an MRI scan (which takes very detailed pictures of your body) and a PET scan (which shows how active cells are using a special sugar tracer).

Why is this study important?

This study aims to see if PET-MRI scans can help doctors predict earlier how well rectal cancer is responding to treatment. This could help them make better, more personalized treatment decisions for patients.

Will I still get my normal cancer treatment if I join?

Yes, you will still receive your planned chemotherapy and radiotherapy as usual. The study adds extra PET-MRI scans to your treatment plan.

Are there any side effects from the PET-MRI scan?

You'll have a small injection for the PET part of the scan. There's a very small amount of radiation from the PET part, and some people might have a mild reaction to the injection, but serious side effects are rare.

How to find out more

Manon VOEGELIN

promotion-rc@icans.eu +33 6 68 33 95 23 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.