Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

• ClinicalTrials.gov Identifier: NCT01444209
• Recruitment Status: Recruiting
• First Posted: September 30, 2011
• Last Update Posted: August 20, 2020
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: September 22, 2011
• First Posted Date: September 30, 2011
• Last Update Posted Date: August 20, 2020
• Actual Study Start Date: September 30, 2011
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 29, 2011): Partial response (reduction in 30% of tumor volume) or greater response within 12 months from the implant procedure. [ Time Frame: 12 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 29, 2011)

• Change of the patient's Humphrey visual field testing [ Time Frame: 5 years ]
• Potential toxicities associated with interstitial seed placement [ Time Frame: 5 years ]
• Progression free survival [ Time Frame: 5 years ]
• The effect of the treatment on quality of life evaluations (patient reported outcomes) [ Time Frame: 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 [ Time Frame: 5 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas
• Official Title: Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pituitary Macroadenoma

Intervention

Radiation: Iodine Implants

Interstitial Radioactive Iodine Implants

Study Arms

Experimental: Radiation Therapy

Interstitial Radioactive Iodine Implants

Intervention: Radiation: Iodine Implants

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 29, 2011): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sarah Hardee, MS; 2146458525; sarah.hardee@utsouthwestern.edu

Contact: Kajal Desai, MS; 2146458525; kajal.desai@utsouthwestern.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01444209
• Other Study ID Numbers: STU 042011-075
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Texas Southwestern Medical Center
• Study Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: January 2020