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Radioisotope Therapy

90Yttrium Colloid for Pituitary Cancer

Phase 3

Recruiting

Research Sponsored by David Clarke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who require surgical intervention as determined by the treating neurosurgeon

Patients 17 years of age or older

Must not have

Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent (90yttrium colloid)

Having a solid tumour

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 3 weeks of treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test the safety and effectiveness of a new treatment for cystic pituitary lesions. The treatment is the stereotactic intracavitary instillation of 90yttrium colloid, and it will be compared to the other available treatment options.

Who is the study for?

This trial is for adults over 17 with cystic tumors in the pituitary region, confirmed by tests or imaging. Candidates must need surgery as per a neurosurgeon's assessment, be managed at the Halifax Neuropituitary Program surgical clinic, and agree to both surgery and study participation. Pregnant or breastfeeding individuals, those allergic to 90yttrium colloid, at high surgical risk, or with solid tumors cannot join.

What is being tested?

The trial is testing an experimental treatment where a radioactive substance called 90yttrium colloid is placed directly into the cystic lesions of the pituitary area using stereotactic techniques. This approach aims to treat these challenging tumors without major risks associated with traditional surgeries or external radiation.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions to the radiopharmaceutical agent (like allergies), complications from its direct placement into brain tissue (such as neurological deficits), and general risks related to invasive procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My neurosurgeon has decided I need surgery.

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I am 17 years old or older.

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I am willing to have surgery and understand the risks involved.

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I have a diagnosed cyst near my pituitary gland.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not allergic to the drug 90yttrium colloid.

Select...

I have a solid tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 3 weeks of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 3 weeks of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 weeks of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cyst shrinkage

Secondary study objectives

Localization of intracystic 90yttrium colloid by PET-CT

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 90yttrium colloidExperimental Treatment1 Intervention

90 Yttrium colloid will be inserted into the cystic cavity. Based on clinical expertise, the treating neurosurgeon will determine the appropriate surgical procedure for each patient on an individual basis which will be reflected in the surgical consent the patient is presented and signs.

0 / 6Eligibility criteria met