Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

• ClinicalTrials.gov Identifier: NCT01444209
• Recruitment Status: Terminated
• First Posted: September 30, 2011
• Results First Posted: November 30, 2021
• Last Update Posted: November 30, 2021
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Robert Timmerman, University of Texas Southwestern Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pituitary Macroadenoma	Radiation: Iodine Implants	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas
• Actual Study Start Date: September 30, 2011
• Actual Primary Completion Date: October 20, 2020
• Actual Study Completion Date: January 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Radiation Therapy; Interstitial Radioactive Iodine Implants	Radiation: Iodine Implants; Interstitial Radioactive Iodine Implants

Outcome Measures

Primary Outcome Measures :

1. Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure. [ Time Frame: 12 months ]

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Robert Timmerman, MD; University of Texas Southwestern Medical Center

  Study Documents (Full-Text)

Documents provided by Robert Timmerman, University of Texas Southwestern Medical Center:

Study Protocol and Statistical Analysis Plan  [PDF] September 24, 2015

More Information

• Responsible Party: Robert Timmerman, Professor, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT01444209
• Other Study ID Numbers: STU 042011-075
• First Posted: September 30, 2011
• Results First Posted: November 30, 2021
• Last Update Posted: November 30, 2021
• Last Verified: November 2021

Keywords provided by Robert Timmerman, University of Texas Southwestern Medical Center:

pituitary gland

Additional relevant MeSH terms:

Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases