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Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

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

Tracking Information
First Submitted Date  ICMJE September 22, 2011
First Posted Date  ICMJE September 30, 2011
Last Update Posted Date August 20, 2020
Actual Study Start Date  ICMJE September 30, 2011
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pituitary Macroadenoma
Intervention  ICMJE Radiation: Iodine Implants
Interstitial Radioactive Iodine Implants
Study Arms  ICMJE Experimental: Radiation Therapy
Interstitial Radioactive Iodine Implants
Intervention: Radiation: Iodine Implants
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 29, 2011)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Hardee, MS 2146458525 sarah.hardee@utsouthwestern.edu
Contact: Kajal Desai, MS 2146458525 kajal.desai@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01444209
Other Study ID Numbers  ICMJE STU 042011-075
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert Timmerman, MD University of Texas Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP