Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

Study Overview
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Brief Summary
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This study is a single arm Phase II pilot trial. Patients enrolled on the trial will undergo implantation of high activity iodine-125 seeds into their pituitary adenoma. The tumor response to treatment will be monitored as well as change in visual fields, associated adverse effects, progression free survival and patient reported outcomes.

Official Title
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Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas

Conditions
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Pituitary Macroadenoma

Intervention / Treatment
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* Radiation: Iodine Implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological or radiographic diagnosis of a pan-invasive pituitary macroadenoma Pan-invasive for the purposes of the protocol will be defined as meeting each of the following 2 major criteria: (1). tumor volume greater than 20 cc at enrollment, and (2). suprasellar extension. In addition, a pan-invasive tumor must meet any one of the following 3 minor criteria, a) unresectable tumor invasion into a cavernous sinus, b) bone or bone marrow invasion into the clivus or temporal bones, or c) tumor extension in any direction unlikely to be completely removed by specifically a transphenoidal surgical approach. Patients who meet the two major criteria above (1 and 2) and are medically inoperable for tumor resection (due to confounding co-existing medical problems) are eligible without meeting any of the three minor criteria (a, b, or c). Patients should be immediately threatened for vision loss or other significant neurological impairment directly related to tumor mass effect. As such, all patients enrolled would likely benefit from tumor response (shrinkage). Patients must have visible tumor on imaging studies (MRI or CT) The patient's Zubrod performance status must be 0-3. Patients must be at least 18 years of age. Mandatory Imaging Studies: Must be done 45 or fewer days prior to : MRI or CT scan of the brain including the entire skull base and all areas of tumor extension Exclusion Criteria: Patients who are unable to undergo general anesthesia Patients who are unable to undergo placement of a stereotactic head frame Patients who are unable to provide informed consent Patients who are pregnant or nursing Patients with severe kidney dysfunction Patients who have contraindications to MRI, such as implanted pacemaker device Patients with diagnosis of pituitary carcinoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiation Therapy<br>Interstitial Radioactive Iodine Implants | Radiation: Iodine Implants<br>* Interstitial Radioactive Iodine Implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the Patient's Humphrey Visual Field Testing |  | 5 years | 
| Potential Toxicities Associated With Interstitial Seed Placement |  | 5 years | 
| Progression Free Survival |  | 5 years | 
| The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes) |  | 5 years | 
| The Cost-utility of the Treatment Arm (in Terms of the Primary Outcome) in Comparison With Other Widely Accepted Cancer and Non-cancer Therapies |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pituitary gland