RecruitingNAINTERVENTIONAL

FAZA PETMRI Gastro-Oesophageal Study

This study is for people with advanced stomach or food pipe cancer that has spread. We are testing a new scanning method called FAZA PET/MRI. This scan uses a special 'dye' to show areas in the cancer that have low oxygen, which can make the cancer harder to treat. Doctors currently don't have a reliable way to predict how well chemotherapy will work. By doing this scan before and after chemotherapy, we hope to learn if it can help predict how patients will respond. Ultimately, we want to find better ways to choose treatments for advanced cancer, so patients can live longer and have a better quality of life with fewer side effects.

At a glance

Status

Recruiting

Phase

Sponsor

University Health Network, Toronto

Enrolment target

Start

15 Sep 2020

Estimated completion

31 Dec 2027

Metastasized Gastro-Oesophageal Cancer

What is this study about?

This study is focusing on a type of cancer that starts in the stomach or food pipe (oesophagus) that has spread to other parts of the body. Unfortunately, this kind of cancer often becomes very serious, and doctors are looking for better ways to understand and treat it.

Currently, when someone has this advanced cancer, they are often given chemotherapy drugs. However, doctors don't have a good way to tell beforehand which patients will respond well to these treatments. If the chemotherapy doesn't work, patients can become very unwell quickly, which makes it harder to try other treatments. One reason treatments might not work is if parts of the cancer have very low oxygen levels, which can make the cancer more aggressive and resistant to medication.

This study is using a special type of scan called PET/MRI. This scan combines two powerful imaging techniques. It also uses a special 'dye' or radiotracer called FAZA. This FAZA dye helps highlight areas in the cancer that have low oxygen. By performing this scan before and after chemotherapy, the study hopes to see if the information from the FAZA PET/MRI can help predict how well a patient's cancer will respond to treatment. The main goal is to see if this scan can help doctors pick the most effective treatment for each person, leading to better outcomes and a better quality of life.

Key takeaways

This study uses a special scan called FAZA PET/MRI.
It aims to better understand and treat advanced stomach or food pipe cancer.
The scan checks for low oxygen areas in the cancer, which can impact treatment.
Your standard cancer treatment will not be affected by participating.
It could help doctors choose more effective treatments for patients in the future.

Who may be eligible?

This study is looking for volunteers aged 18 or older who have stomach or food pipe cancer that has spread to other parts of the body. You also need to have healthy kidney function.

There are some reasons why you might not be able to join. For example, if you have any metal implants or other conditions that prevent you from having an MRI scan, or if you can't lie still for about 30 minutes. Also, if you are pregnant or breastfeeding, you won't be able to take part.

Finally, if you are allergic to certain contrast dyes used in scans or to ethanol (alcohol, which is in the FAZA preparation), you would not be able to join this 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.

Are you 18 years old or older?
Do you have stomach or food pipe cancer that has spread?
Can you lie still for about 30 minutes for a scan?
Are you NOT pregnant or breastfeeding?
Do you NOT have an allergy to common contrast dyes or ethanol (alcohol)?

Answer every question to see your result.

What does participation involve?

If you join this study, your normal cancer treatment will not be changed based on the study findings. You will have a special FAZA PET/MRI scan before you start your standard chemotherapy. You will then have a second FAZA PET/MRI scan after you have completed some of your standard chemotherapy treatments. These scans involve lying still in a scanner for a period of time after receiving the special FAZA dye. Beyond these two scans, your involvement specifically with the study will not involve extra medication or long-term follow-up beyond your usual medical care. The total duration of your active participation, mainly consisting of the two scans, will depend on your chemotherapy schedule.

Potential risks and benefits

One potential benefit of taking part is contributing to research that could help future patients with advanced stomach or food pipe cancer by finding better ways to predict treatment success. You will also receive detailed scans of your cancer. Potential risks mainly relate to the scans themselves, such as possible mild allergic reactions to the contrast dye used, or discomfort from lying still. There's also a very small exposure to radiation from the PET scan. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (1)

Univeristy Health Network
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is FAZA PET/MRI?

It's a special scan that combines two types of imaging (PET and MRI) and uses a tracer called FAZA to show areas in the cancer with low oxygen.

Why is low oxygen in cancer important?

Cancer areas with low oxygen can be more aggressive and harder to treat with standard chemotherapy.

Will my treatment change if I join the study?

No, your regular cancer treatment prescribed by your doctor will not change because of this study.

How many scans will I have?

You will have two extra scans: one before starting chemotherapy and one after part of your chemotherapy.

What is the 'dye' used in the scan?

It's called 18F-Fluoroazomycin Arabinoside (FAZA), and it's a special substance injected into your body to help the scan show specific things.

How to find out more

Nirushini Sivasothy

nirushini.sivasothy@uhn.ca 416-946-4501 Official trial record

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