Not yet recruitingOBSERVATIONAL

18FFDG PET/CT for Early Evaluation of Chemotherapy Efficacy in Metastatic Colic Adenocarcinoma

This study is investigating if a special scan, called a PET/CT scan, can quickly tell doctors if chemotherapy is working for people with bowel cancer that has spread. Bowel cancer that has spread, especially to organs like the liver or lungs, is a serious health issue. Current methods to check if chemotherapy is working can take many months. If the PET/CT scan can show success earlier, it could help doctors make quicker decisions about treatment. This might mean changing medicines or adjusting the treatment plan sooner. The aim is to make sure patients get the most effective treatment for their type of cancer as quickly as possible.

At a glance

Status

Not yet recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

222

Start

01 Sep 2022

Estimated completion

01 Sep 2027

Metastatic Colorectal Cancer

What is this study about?

This study is about people who have bowel cancer that has spread to other parts of their body, like their liver or lungs. This is sometimes called metastatic bowel cancer. Treating this type of cancer is often complex and involves strong chemotherapy drugs, sometimes combined with other targeted medicines.

Currently, it can take quite a long time – often three to four months – to see if the chemotherapy is truly effective using standard scans. This study is testing if a special type of scan, called an 18FFDG PET/CT scan, can show much sooner whether the treatment is working. PET/CT scans are already used for other cancers like lymphoma and breast cancer to check treatment success.

The main goal is to find out if using these PET/CT scans early in treatment can predict how well a patient will respond to chemotherapy. If the scans prove to be accurate early on, it could be a major step forward. Doctors might be able to discover sooner whether a chemotherapy plan is right for a patient, and if not, they could change it more quickly. This could involve trying a different combination of chemotherapy drugs to give patients the best possible chance of successful treatment.

Key takeaways

This study uses a PET/CT scan to check early chemotherapy success for advanced bowel cancer.
The goal is to help doctors make quicker treatment decisions.
It could allow for earlier changes to chemotherapy if initial treatment isn't working.
Participation involves receiving standard chemotherapy plus additional scans.
It aims to improve how doctors monitor and manage advanced bowel cancer treatment.

Who may be eligible?

To be considered for this study, you need to have bowel cancer that has been confirmed by a biopsy, and it must have spread to other parts of your body. Doctors must believe that these areas of cancer that have spread could potentially be removed by surgery in the future. You should also generally be well enough to receive treatment, meaning you can mostly care for yourself and your daily activities aren't too affected by your illness.

You must be starting your first course of chemotherapy for this cancer, which might also include 'targeted therapy' drugs. If you've had chemotherapy in the past for this cancer when it was in one spot (adjuvant chemotherapy), it needs to have stopped more than six months before your current cancer spread was found. You also need to be over 18 years old and expected to live for more than six months based on your overall health.

You cannot join the study if your cancer has spread to your brain. You also can't take part if you are pregnant or breastfeeding, have another active cancer, or have ever had a severe allergic reaction to the substances used in the PET/CT scan (called FDG). If you're involved in another study that uses radiation scans, you also won't be able to join this one.

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 you have bowel cancer that has spread to other parts of your body?
Are you about to start your first course of chemotherapy for this advanced cancer?
Are you generally well and over 18 years old?
Do your doctors think your cancer that has spread could potentially be surgically removed?
Are you *not* pregnant or breastfeeding, and do you *not* have another active cancer?

Answer every question to see your result.

What does participation involve?

The detailed steps of taking part in this study are not fully described in this summary. However, generally, if you join a study like this, you would receive the standard first-line chemotherapy your doctors recommend. You would have a special scan, called an 18FFDG PET/CT scan, early in your treatment. This scan would be in addition to the usual scans you would have to check your cancer. The study is particularly interested in how these early scans compare to later scans or other methods for checking treatment response. The total duration of your participation would depend on your treatment plan and the specific follow-up required by the study.

Potential risks and benefits

Participating in this study might offer the potential benefit of closer monitoring of your treatment, which could lead to quicker adjustments if the chemotherapy isn't working as expected. However, attending additional scans means extra time at the hospital and exposure to a small amount of radiation from the PET/CT scan. As with all clinical trials, there are no guarantees of direct personal benefit. You will be fully informed of all potential risks and benefits before deciding to join, and you always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Hôpital Saint Louis
Verified postcode
Paris, France

Common questions

What is a PET/CT scan?

A PET/CT scan is a type of imaging test that combines two scan types (PET and CT) to create detailed pictures of the inside of your body. It can show where cancer cells are and how active they are.

Why do this study?

This study aims to see if PET/CT scans can tell doctors very early on if chemotherapy for advanced bowel cancer is working, potentially allowing for faster treatment changes if needed.

Will I still get my normal chemotherapy?

Yes, you would still receive the standard chemotherapy and any targeted therapies that your doctor recommends for your condition.

What is 'metastatic' cancer?

Metastatic cancer means the cancer has spread from where it started (in this case, your bowel) to other parts of your body, like your liver, lungs, or lining of your abdomen.

Can I leave the study once I've joined?

Yes, you are always free to leave the study at any point without having to give a reason, and it will not affect your medical care.

How to find out more

Laetitia Vercellino, MD

laetitia.vercellino@aphp.fr +33142499411 Official trial record

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