Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase I study to evaluate the safety and dosimetry of 68Ga-OncoCAIX in patients with CAIX-positive cancer

This is a very early study, called a Phase I trial, looking at a new type of medical scan. The scan uses a special substance called 68Ga-OncoCAIX. Doctors want to see if this new scan is safe for people to have and how well it helps them see a specific type of kidney cancer, called clear cell renal cell carcinoma. The main purpose is to establish the safety of this new scan and determine how the medicine travels through the body to reach the cancer cells. This information is crucial for future research to develop better ways to find and treat this cancer. The study is open to adults aged 18 and over, regardless of their gender.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Philogen S.p.A.

Enrolment target

Start

27 Nov 2024

Patients with suspected clear cell renal cell carcinoma (ccRCC)

What is this study about?

This study is about a new kind of special scan called 68Ga-OncoCAIX. Think of it like a new way to take a very detailed picture inside your body. The main goal is to see if this new scanning method is safe for people to use, especially those who have a type of kidney cancer called clear cell renal cell carcinoma (ccRCC).

When we talk about 'scanning', it's similar to other scans you might have heard of, but this one uses a special substance designed to light up specific cancer cells. Doctors want to understand how much of this special substance gets to the cancer and how long it stays there. This helps them work out the best way to use it in the future.

This is a 'Phase I' study, which means it's one of the very first times this new scan is being used in people. It's an important step in developing new tools to help identify and, eventually, treat cancer. By finding out if it's safe and how it works in the body, researchers can decide if it's worth continuing to test as a potential diagnostic tool.

Key takeaways

This is an early-stage study testing a new scan, not a new treatment.
The scan aims to help doctors see a specific type of kidney cancer.
The main goals are to check the scan's safety and how it works in the body.
It's open to adults aged 18 and over with suspected clear cell renal cell carcinoma.
Participation helps advance medical knowledge for future cancer diagnosis.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. It is suitable for both men and women. The study is specifically looking for people who are thought to have a particular type of kidney cancer called clear cell renal cell carcinoma.

There might be other health conditions or medications you are taking that would mean you couldn't join, as the research team needs to make sure it's safe for everyone involved. For example, if you have certain other serious health problems, this study might not be right for you.

The best way to find out if you qualify is to talk to your doctor. They can check all the detailed requirements and see if this study could be an option for you.

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 suspected clear cell renal cell carcinoma (a type of kidney cancer)?
Are you able to attend appointments at a hospital or clinic?
Are you able to understand and agree to the study requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have a few appointments at a hospital or clinic. These visits would involve being given the special substance for the scan, then having the scan itself. You might also have blood tests and other checks to make sure you are well throughout the study. The doctors would be looking closely at how your body reacts to the scan substance.

This study is focused on the scan itself, so it doesn't involve taking new medications or treatments for your cancer. The exact number of visits, how long each visit lasts, and total time in the study would depend on the study plan, but you would be given all this information in detail before you agree to take part. There would also likely be follow-up calls or shorter visits after the main scan to check on how you are doing.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits. You would be helping doctors learn more about a new way to detect cancer, which could help many people in the future. You might also get more detailed information about your own health condition. However, because this is a very early-stage study, there's no guarantee that you personally will experience any direct medical benefit from the scan. As with any medical procedure, there are potential risks, such as side effects from the scan substance or discomfort during the scanning process. All potential risks would be fully explained to you before you agree to take part. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Italy

Common questions

What is this scan for?

This new scan, called 68Ga-OncoCAIX, is being tested to see if it can safely help doctors identify a specific type of kidney cancer called clear cell renal cell carcinoma.

Is this a new treatment for cancer?

No, this study is about a new type of scan to help *find* or *see* the cancer better, not a new treatment for it. It helps doctors get more information.

What does 'Phase I' mean?

Phase I means this is one of the very first times this new scan is being used in people. The main goals are to make sure it's safe and to understand how it works in the body.

Will I get my scan results?

The study team will explain if and how you will receive information from your scan. Sometimes, new scan results in early studies are for research purposes rather than immediate medical decisions.

Can women take part?

Yes, this study is open to both men and women, as long as they meet the other study requirements.