Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

Phase 2

Terminated

• Conditions: Pituitary Macroadenoma
• Interventions: Radiation: Iodine Implants

• Registration Number: NCT01444209
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-29
• Study Start: 2011-09-30
• Study First Posted: 2011-09-30
• Primary Completion: 2020-10-20
• Study Completion: 2021-01-20
• Results First Submitted: 2021-10-21
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Results First Posted: 2021-11-30
• Last Update Posted: 2021-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation Therapy	Iodine Implants	Interstitial Radioactive Iodine Implants

Primary Outcome Measures

Name	Time	Method
Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.	12 months

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival	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
Potential Toxicities Associated With Interstitial Seed Placement	5 years
Change of the Patient's Humphrey Visual Field Testing	5 years
The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes)	5 years

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States