RecruitingPHASE1, PHASE2INTERVENTIONAL

Evaluation of 89Zr-DFO-nimotuzumab for Non-invasive Imaging of EGFR+ Cancers by Positron Emission Tomography (PET)

This research study is trying to find a new and simpler way to detect certain types of cancer cells in people with lung or bowel cancer. These particular cells have something called 'EGFR' on their surface, which is common in many aggressive cancers. Currently, finding these cells can involve invasive tests. We're testing a special medicine, 89Zr-DFO-nimotuzumab, which we believe will attach specifically to these EGFR-positive cancer cells. After you receive a small dose, we'll use a PET-CT scan, like an advanced X-ray, to see if these cells light up. If successful, this could help doctors decide which cancer treatments, especially those targeting EGFR, are most likely to work for each person, without needing more invasive procedures.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

University of Saskatchewan

Enrolment target

Start

01 Feb 2020

Estimated completion

01 Dec 2026

Lung Cancer Colorectal Cancer

What is this study about?

Many aggressive cancers, including some lung and bowel cancers, have a special protein called EGFR (Epidermal Growth Factor Receptor) on the surface of their cells. Think of EGFR as a tiny antenna that helps the cancer cells grow and spread. Knowing if a cancer has a lot of these EGFR 'antennas' is really important because there are specific medicines designed to block them. Currently, finding out if a cancer has these EGFR proteins can involve taking a tissue sample, which is a small operation, or other tests that aren't always reliable. We need a better, less invasive way to get this important information so doctors can choose the most effective treatments for each person.

This study is testing a new approach using a special type of medicine called 89Zr-DFO-nimotuzumab. This medicine is designed to stick specifically to the EGFR proteins on cancer cells. We also add a very small, safe amount of a material that can be seen by a PET-CT scanner. A PET-CT scan is a type of imaging that can take detailed pictures inside your body. The idea is that if the medicine sticks to the cancer cells with EGFR, those parts of your body will 'light up' on the scan.

By seeing these EGFR-positive cancer cells on a scan, without needing a biopsy, doctors could make more informed decisions about treatment. For example, if your scan shows a lot of EGFR, doctors might recommend specific anti-EGFR medicines, like nimotuzumab, knowing they are more likely to be effective for you. This trial will help us understand if this new scanning method works, how long after giving the medicine is the best time to scan, and how well it can help us choose treatments.

Key takeaways

Looks for a new, less invasive way to detect EGFR-positive cancer cells.
Uses a special medicine and a PET-CT scan to make cancer cells 'light up'.
Aims to help doctors choose more targeted treatments for lung and bowel cancers.
Specifically for people with confirmed EGFR-positive lung or bowel cancer.
Involves receiving a small injection and having a scan.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult between 18 and 80 years old. It's important that a doctor has already confirmed that your cancer (either lung or bowel) has a high level of the EGFR protein. You would also need to have a tumour that's at least 1.5 cm big, which doctors can see on scans or feel during an examination.

You should feel well enough to participate in the study activities, which your doctor will assess. If you are a woman who could have children, you must not be pregnant or breastfeeding, and you would need a negative pregnancy test shortly before getting the study medicine. Alternatively, you would be past menopause or have had certain surgeries that prevent pregnancy.

A key point is that you should not have received any anti-EGFR antibody treatments before joining this study. Also, you must be able to lie still for about an hour for a PET scan. The study team will make sure you understand everything and are happy to take part before you make any decisions.

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 between 18 and 80 years old?
Has a doctor confirmed your cancer (lung or bowel) has the EGFR protein?
Are you able to lie still for about an hour for a scan?
Have you NOT had anti-EGFR antibody treatments before?
If you are a woman, are you definitely not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive a very small amount of the study medicine, 89Zr-DFO-nimotuzumab, either 1mg or 50mg, given as an injection. After receiving the medicine, you will have a special scan called a PET-CT scan. This scan involves lying still for about an hour while the scanner takes pictures. The study will involve several visits for these procedures and check-ups to monitor your health. The total duration of your involvement will depend on how many scans and follow-up visits are needed, which the study team will explain fully. They will also tell you if any other tests or assessments are required during your time in the study.

Potential risks and benefits

Potential benefits of taking part could include helping doctors find a better way to choose treatments for cancer patients in the future, particularly those with EGFR-positive cancers. This study may not directly benefit you, but the information gained is valuable for others. As with any medical procedure, there are potential risks, such as side effects from the study medicine or discomfort during the scan. However, the dose of medicine is carefully controlled, and the team will closely monitor you. You will be given full details of these possible risks. Remember, taking part in this study is completely voluntary, and you are free to withdraw at any time without affecting your usual medical care.

Locations (1)

Royal University Hospital
Verified postcode
Saskatoon, Canada· Recruiting

Common questions

What is EGFR?

EGFR is a protein found on the surface of some cancer cells that helps them grow. Finding out if a cancer has a lot of EGFR can help doctors choose specific treatments.

What is a PET-CT scan?

A PET-CT scan is a special type of imaging that combines two scans to give very detailed pictures inside your body. It can show how organs and tissues are working.

Is the study medicine safe?

The study medicine is given in very small, carefully controlled amounts. We will closely monitor you for any side effects, and you will be informed of all known potential risks.

Will this study cure my cancer?

This study is primarily for research to find a better way to detect cancer cells. While it might help inform future treatment decisions, it's not designed as a direct cure for your cancer.

Can I continue my regular treatments during the study?

That will depend on your specific situation and the type of treatment. The study team will discuss this with you in detail before you decide to take part.

How to find out more

Rajan Rakheja, MD

rajan.rakheja@gmail.com 306-655-2932 Official trial record

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