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Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

This study is currently recruiting participants.
Verified January 2017 by University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444209
First Posted: September 30, 2011
Last Update Posted: January 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  Purpose
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 Intervention Phase
Pituitary Macroadenoma Radiation: Iodine Implants Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: October 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation Therapy
Interstitial Radioactive Iodine Implants
Radiation: Iodine Implants
Interstitial Radioactive Iodine Implants

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444209


Contacts
Contact: Robert Timmerman, MD 214-645-8525
Contact: Jean Wu, MSN 214-645-8525

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Robert Timmerman, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert Timmerman, MD University of Texas Southwestern Medical Center
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01444209     History of Changes
Other Study ID Numbers: STU 042011-075
First Submitted: September 22, 2011
First Posted: September 30, 2011
Last Update Posted: January 9, 2017
Last Verified: January 2017

Keywords provided by 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
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs