Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Evaluation of 64Cu-ATSM PET/CT as a predictor of response to neoadjuvant therapy in locally advanced rectal cancer (TEP-64Cu-ATSM-Rectum)

This research study is for people with advanced bowel cancer that affects the rectum. Doctors are trying to see if a special type of scan, called a PET/CT scan, using a tracing substance called 64Cu-ATSM, can help predict how well a patient will respond to their pre-surgery treatments. These treatments are often given to shrink the cancer before an operation. By understanding how well treatments are likely to work beforehand, doctors hope to personalise care more effectively. This is a Phase II study, meaning it's an early-stage trial looking at how safe and effective this new approach might be. It includes adults aged 18 and over, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut De Cancerologie De L Ouest

Enrolment target

Start

18 Jun 2024

Rectal adenocarcinoma

What is this study about?

This study is about helping people who have a type of bowel cancer called rectal adenocarcinoma, which is cancer found in the last part of the large intestine. Before surgery, patients often receive treatments to try and shrink the cancer first. This is called 'neoadjuvant therapy'. These treatments might include chemotherapy or radiotherapy, or a combination.

The main idea of this research is to see if a special scan, using a harmless tracing substance called 64Cu-ATSM, can predict how well these pre-surgery treatments are going to work for an individual. This scan is a type of PET/CT scan, which combines two powerful imaging techniques. If doctors can predict a patient's response early on, it could help them choose the best treatment plan that is most likely to be effective for that specific person.

Ultimately, the goal is to make cancer treatment more effective and personalised. This study is in an early stage (Phase II), which means researchers are carefully studying this new approach to see if it's safe and if it provides useful information that could improve how we treat rectal cancer in the future.

Key takeaways

Looks at if a special scan can predict treatment success for rectal cancer.
Aims to predict how pre-surgery treatments will work.
Involves a PET/CT scan using a tracer called 64Cu-ATSM.
This is a research study to improve future patient care.
Only for people with locally advanced rectal cancer receiving pre-surgery treatments.
Doesn't change your planned cancer treatment.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. The study welcomes both men and women.

You would have been diagnosed with rectal adenocarcinoma, which is a cancer in the last part of your bowel, and your healthcare team would have advised you to have treatments before any surgery.

There will be other specific health requirements that the study doctors will check to make sure participating is safe and appropriate for you. Your current health and any other medical conditions you have will be reviewed carefully.

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 advanced rectal cancer?
Are you due to receive treatments before surgery for your cancer?
Are you generally well enough to have extra scans?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the standard pre-surgery treatments for your rectal cancer, just as you would normally. The main change would be having additional special scans (PET/CT scans with 64Cu-ATSM) at specific times during your treatment plan. This might mean extra visits to the hospital or clinic for these scans.

You would continue to have regular check-ups, blood tests, and other assessments as part of your standard care. The total duration of your participation would depend on your individual treatment plan, but it would cover the period of your pre-surgery treatments and likely a follow-up after surgery to see how well the predictions matched your actual response.

Potential risks and benefits

Taking part in a clinical trial offers the chance to contribute to medical knowledge and potentially help others in the future. For you, the main benefit is that your care would be closely monitored. The scan itself involves a small amount of a radioactive tracer, which is generally considered safe, but there's a very small risk associated with radiation exposure, similar to other medical scans. There might be minor discomfort or allergic reactions, though these are rare. You are always free to withdraw from the study at any time, for any reason, without it affecting your standard medical care.

Locations (1)

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

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Unverified
France

Common questions

What is 64Cu-ATSM?

It's a special, harmless tracing substance that is given to you before the PET/CT scan. It helps doctors see certain things about your cancer more clearly on the scan.

What is a PET/CT scan?

It's a type of scan that combines two powerful imaging methods. It helps doctors see detailed pictures of your body and how your cells are working.

Will this study change my cancer treatment plan?

No, your planned treatments for cancer will remain the same. The study is about seeing if the scan can predict how well those treatments are working, not to change them initially.

Is this a new medicine trial?

No, this study is not testing a new cancer medicine. It's looking at a new way to get information about your cancer using a special scan, alongside your existing treatments.

How long will I be in the study?

Your participation will cover your pre-surgery treatments and probably a follow-up period after your surgery. The exact time will depend on your individual treatment schedule.