RecruitingOBSERVATIONAL

Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems

This research is exploring a new approach to keep an eye on how well treatment is working for rectal cancer. Patients with newly diagnosed rectal cancer who are undergoing a combination of chemotherapy and radiotherapy (called neo-adjuvant chemo-radiation) are being studied. The main goal is to see if a specific type of MRI scan, performed during the radiotherapy sessions, can provide an early warning sign of whether the cancer is shrinking. This 'diffusion sequence' on the MRI machine could help doctors understand sooner if the treatment is effective. Ultimately, this could lead to more personalised and timely adjustments to treatment plans, aiming to give patients the best possible outcomes.

At a glance

Status

Recruiting

Sponsor

Institut Paoli-Calmettes

Enrolment target

Start

08 Jun 2020

Estimated completion

01 May 2027

Rectal Adenocarcinoma

What is this study about?

This study is about finding a better way to check if treatment for rectal cancer is working. When someone has rectal cancer, they often receive a combination of chemotherapy and radiotherapy before surgery. This is called 'neo-adjuvant chemo-radiation' and it aims to shrink the tumour before an operation.

The researchers want to see if a special type of MRI scan can give an early signal about how well this treatment is affecting the cancer. This MRI scan would be done using a machine that combines an MRI scanner with radiotherapy equipment. They will use a specific part of the MRI scan, called a 'diffusion sequence', to look for changes in the cancer cells.

The idea is that if doctors can tell earlier whether the treatment is working, they might be able to make changes to the treatment plan sooner. This could help make the treatment more effective for each person, potentially leading to better results and making sure patients get the most appropriate care.

Key takeaways

This study explores a new way to check if rectal cancer treatment is working early on.
It uses special MRI scans done during radiotherapy sessions.
The goal is to improve how doctors monitor treatment and potentially personalise care.
You will receive your usual treatment, with no extra medication or appointments.
This research could help many future patients with rectal cancer.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with rectal cancer that your doctors have decided should be treated with chemotherapy and radiotherapy before surgery. You'll also need to be fit enough for treatment, which doctors measure using scores like the Karnofsky Index (KPS) or ECOG, and you must agree to take part by signing a consent form.

There are several reasons why you might not be able to join. For example, if your tumour mainly contains a substance called mucin, which can affect the MRI results. Also, if you can't have an MRI scan due to things like a pacemaker or severe claustrophobia, then this study wouldn't be suitable. If you're pregnant, breastfeeding, or participating in another medical study for the same condition, you also wouldn't be able to take part.

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 18 years old or older?
Do you have rectal cancer that your doctors have recommended chemotherapy and radiotherapy for?
Are you able to have an MRI scan (e.g., no pacemakers, not severely claustrophobic)?
Are you not currently pregnant or breastfeeding?
Are you able to understand and sign a consent form to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you will go through your usual treatment for rectal cancer, which includes chemotherapy and radiotherapy. The main difference is that during your radiotherapy sessions, a special type of MRI scan will be performed at the same time. This scan will collect additional information about your tumour.

There won't be any extra hospital visits beyond what's already planned for your standard treatment. The researchers will simply be using the information from these special MRI scans to see if they can predict how well your treatment is working. The total duration of your participation would cover your pre-surgery treatment period.

Potential risks and benefits

The main benefit of this study is that it could help develop a better way to monitor rectal cancer treatment in the future. By joining, you're contributing to medical research that might improve care for others. There are no direct personal health benefits expected during the study itself, as it's an observational study of your existing treatment. The extra MRI scans are done at the same time as your standard treatment, so they shouldn't cause additional discomfort or risks beyond what you would normally experience with an MRI. You are free to withdraw from the study at any time without affecting your medical care.

Locations (2)

University of California Los Angeles (UCLA)
Verified postcode
Los Angeles, United States· Not yet recruiting
Institut Paoli Calmettes
Verified postcode
Marseille, France· Recruiting

Common questions

What is the main goal of this study?

The study aims to see if a special type of MRI scan can show early on if rectal cancer treatment is working well.

Will I receive a new kind of treatment if I join?

No, you will receive your standard chemotherapy and radiotherapy treatment. The study is about how we monitor that treatment.

What is 'MRI-guided radiotherapy (MRgRT)'?

It's a special machine that combines an MRI scanner with radiotherapy equipment, allowing doctors to see the tumour very clearly while delivering radiation.

Do I need to do anything extra, like take more medication?

No, you won't need to take any extra medication or have extra appointments outside of your planned treatment. The study uses information from the MRI scans done during your radiotherapy.

Is this study safe?

Yes, the study involves using a standard MRI scan technique during your treatment. It doesn't add new health risks beyond your usual treatment and MRI scans.

How to find out more

Dominique GENRE, MD

drci.up@ipc.unicancer.fr 33491223778 Official trial record

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