RecruitingPHASE3INTERVENTIONAL

90Yttrium Colloid for the Treatment of Cystic Sellar/Parasellar Tumors

This study is investigating a new treatment for cysts that form in or around your pituitary gland. These cysts can sometimes cause symptoms because of their size. While surgery and other treatments exist, they don't always fully remove the cyst walls, which can lead to problems. This trial proposes using a special liquid called 90Yttrium colloid, delivered directly into the cyst during surgery, to help treat the cyst lining. Researchers have used this approach successfully on a small number of patients over the past decade, and now Health Canada has requested a formal study to assess its benefits compared to other available treatments. The goal is to find a more effective way to manage these challenging cysts, potentially preventing them from growing back or causing further issues.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

David Clarke

Enrolment target

Start

01 Jun 2014

Estimated completion

31 Oct 2031

Cystic Tumors of the Sellar/Parasellar Region

What is this study about?

You’re reading about a study that focuses on a particular type of growth called a 'cystic tumour' or 'cyst' that can appear in or near your pituitary gland. The pituitary gland is a small but important gland at the base of your brain that controls many of your body's functions. Sometimes, these cysts can grow and press on important parts of your brain, causing symptoms that need treatment.

Currently, there isn't one best way to treat these cystic tumours. Doctors might suggest simply watching the cyst over time with scans, draining the fluid from it, or removing it with surgery. However, removing these cysts completely can be tricky because of their location and the nature of the cyst wall itself, sometimes leading to complications. This study is exploring a new approach called 'intracystic radiotherapy' using a substance called 90Yttrium colloid.

The idea is to put this special liquid directly into the cyst during surgery. This liquid contains a very small amount of radiation that aims to treat the lining of the cyst, hopefully preventing it from growing back or bothering you again. The researchers have already used this method with good results in a small number of patients, and now they want to formally compare it with other treatments to see if it offers a better solution for people like you.

Key takeaways

This study explores a new treatment for cysts near the pituitary gland.
The treatment involves a special liquid put into the cyst during surgery.
It aims to improve how doctors manage difficult cystic tumours.
You must be 17 or older and need surgery for your cyst to be considered.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be at least 17 years old and have a cystic growth in or near your pituitary gland. Doctors will confirm this using scans or tissue samples. It's also important that your doctors believe you need surgery for your cyst and that you are already receiving care at the Halifax Neuropituitary Program surgical clinic.

There are also a few things that would mean you couldn't join the study. For example, if your surgeon thinks surgery would be too risky for you, or if scans show you have a solid tumour rather than a fluid-filled cyst. You also can't be pregnant or breastfeeding. Finally, if you've had a bad reaction to similar medicines in the past, you wouldn't be able to take part.

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 17 years old or older?
Do you have a cystic growth (not a solid one) in or around your pituitary gland?
Has your doctor said you need surgery for this cyst?
Are you currently a patient at the Halifax Neuropituitary Program surgical clinic?
Are you NOT pregnant or breastfeeding?
Are you NOT allergic to similar radioactive medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first need to give your informed consent, meaning you understand what the study involves and agree to participate. You would undergo surgery, as determined by your neurosurgeon, which is the standard procedure for your condition. During this surgery, if you are part of the study, the special liquid (90Yttrium colloid) would be placed directly into your cyst. The specific details of your surgery will be decided by your neurosurgeon, Dr. David B. Clarke, based on his experience. After the surgery, you would continue to be monitored by your doctors, both clinically and with scans, to see how the cyst responds to the treatment. The total duration of your participation would involve the surgery and ongoing follow-up appointments.

Potential risks and benefits

The main benefit of taking part in this study could be access to a new treatment that might be more effective in managing your specific cystic tumour, potentially leading to stable shrinking of the cyst and preventing new issues. However, as with any medical procedure, there are potential risks, including those associated with surgery itself and the administration of the 90Yttrium colloid. These risks will be fully explained to you by the medical team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Halifax Infirmary
Verified postcode
Halifax, Canada· Recruiting

Common questions

What is the pituitary gland?

The pituitary gland is a small gland at the base of your brain. It's often called the 'master gland' because it controls many other glands and body functions.

What is a cystic tumour?

A cystic tumour, in this case, is essentially a fluid-filled sac or growth that forms in or around your pituitary gland. It's different from a solid tumour.

What is 90Yttrium colloid?

It's a special liquid containing a tiny amount of radiation. In this study, it's used directly inside the cyst to help treat its lining.

Will I have surgery if I join this study?

Yes, if you join this study, it's because your doctors have already decided that you need surgery for your cyst. The study treatment is given during this surgery.

What does 'informed consent' mean?

Informed consent means that before you decide to join, the doctors will fully explain everything about the study, including potential risks and benefits. You then sign a form showing you understand and agree to participate.

How to find out more

David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS

d.clarke@dal.ca Official trial record

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