Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Accelerator-based BNCT for head and neck carcinoma

This early-stage medical study is investigating a new type of radiation treatment for people with head and neck cancers. This treatment is called "Accelerator-based BNCT" but simply put, it's a new method of delivering radiation therapy. The main goal at this point is to understand if this new treatment is safe for patients and how their bodies respond to it. This is not a study comparing it to existing treatments, but rather testing a new method. It's open to adult patients (18 years and older) who have head and neck cancer, regardless of whether they are male or female.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

HUS-Yhtymae, Neutron Therapeutics Finland Oy

Enrolment target

Start

16 Oct 2024

Head and neck carcinoma

What is this study about?

This study is about exploring a new way to treat certain head and neck cancers. Doctors and scientists are always looking for better and safer ways to help people, and this study focuses on a new kind of radiation treatment. Think of it like a very early test drive of a new car – they're not trying to see if it's better than an old car yet, but just checking if it can be driven safely and how it handles.

Specifically, this treatment uses something called "Accelerator-based Boron Neutron Capture Therapy" (BNCT). This is a very targeted way of giving radiation. The idea is to direct the treatment very precisely to the cancer cells, hopefully causing less harm to healthy surrounding tissues. Because this is a very new approach, the first step is always to understand its safety and how much treatment the body can handle. This is why it's called a "Phase I" study – it's the very first time it's being tested in people.

The information gathered from this study will be really important for understanding if this new method has the potential to help people with head and neck cancers in the future. It’s a foundational step towards developing new treatments, offering hope for more effective and less harmful options down the line.

Key takeaways

This is an early-stage study (Phase I) for head and neck cancer.
It tests a new type of targeted radiation treatment called BNCT.
The main goal is to check for safety and how the body handles the treatment.
Open to adults aged 18 and older, both men and women, with head and neck cancer.
Participation involves receiving the new treatment and close monitoring.
You can withdraw from the study at any time.

Who may be eligible?

To be able to join this study, there are certain things you need to meet, and some things that might mean you can't take part. This helps the researchers make sure they are studying the treatment in the right group of people and that it's as safe as possible for everyone involved.

First, you must be an adult – that means you need to be 18 years old or older. There is no upper age limit, so people of all adult ages can be considered. Also, this study is open to both men and women.

The most important health requirement for this study is that you must have been diagnosed with head and neck cancer. Other parts of your health and medical history, which aren't fully detailed here, would also be checked by the study doctors to make sure this particular treatment is suitable and safe for you.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of head and neck cancer?
Are you able to travel to the study site for appointments?
Are you comfortable with receiving a new, experimental treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would first have a number of checks to make sure you are suitable. Once enrolled, you would receive the new radiation treatment, which involves special sessions to deliver the therapy. This isn't like a standard single-session treatment; it would likely involve multiple visits over a period.

Throughout the study, you would have regular appointments, tests, and assessments. These are to closely monitor how your body is reacting to the treatment, check for any side effects, and see if the treatment is having an effect on your cancer. This could include blood tests, scans, and physical examinations. After the treatment period, you would have follow-up visits to continue monitoring your health over a set amount of time. The total duration of your participation, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in a study like this means you might be among the first to receive a new type of treatment. While there's no guarantee it will directly benefit your health, researchers hope it could lead to better ways of treating head and neck cancers in the future. The main potential benefit is contributing to medical knowledge that could help many others. For yourself, there's always the possibility of some personal benefit from being closely monitored by medical experts. However, because this is a new treatment, there are unknown risks and potential side effects that your doctors would discuss in detail. You would be closely monitored for any problems. It's very important to remember that joining a study is always your choice, and you are free to withdraw at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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Finland

Common questions

What is head and neck cancer?

Head and neck cancer is a type of cancer that starts in parts of the head and throat, such as the mouth, nose, throat, or voice box.

What does 'Phase I' mean for a study?

Phase I means it's an early-stage study where doctors are mainly checking if a new treatment is safe for people and what the right dose might be. They’re not yet comparing it to existing treatments.

Will I get this new treatment if I join?

Yes, if you meet all the requirements and decide to join this study, you would receive the new Accelerator-based BNCT treatment being tested.

Are there any costs for taking part?

Generally, you do not pay for the study treatment or related appointments. However, you should always ask the study team about any potential costs, such as travel, before you join.

Can I still have my regular doctor?

Yes, you would continue to be cared for by your regular doctors. The study team would work with them and keep them informed about your progress.