Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

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

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.

Study Overview

• Status: Terminated
• Conditions: Pituitary Macroadenoma
• Intervention / Treatment: Radiation: Iodine Implants

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation Therapy; Interstitial Radioactive Iodine Implants	Radiation: Iodine Implants; Interstitial Radioactive Iodine Implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Time Frame
Progression Free Survival	5 years
Change of the Patient's Humphrey Visual Field Testing	5 years
Potential Toxicities Associated With Interstitial Seed Placement	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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2011
• Primary Completion (Actual): October 20, 2020
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: September 22, 2011
• First Submitted That Met QC Criteria: September 29, 2011
• First Posted (Estimate): September 30, 2011

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: pituitary gland
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Hypothalamic Diseases; Pituitary Diseases
• Other Study ID Numbers: STU 042011-075