Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

NCT ID: NCT01444209

Last Updated: 2021-11-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2021-01-20

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.

Conditions

Pituitary Macroadenoma

Keywords

pituitary gland

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation Therapy

Interstitial Radioactive Iodine Implants

Group Type: EXPERIMENTAL

Iodine Implants

Intervention Type: RADIATION

Interstitial Radioactive Iodine Implants

Interventions

Iodine Implants

Interstitial Radioactive Iodine Implants

Intervention Type: RADIATION

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robert Timmerman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Timmerman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU 042011-075

Identifier Type: -

Identifier Source: org_study_id