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Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

Primary Purpose

Pituitary Macroadenoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Iodine Implants
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pituitary Macroadenoma focused on measuring pituitary gland

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation Therapy

Arm Description

Interstitial Radioactive Iodine Implants

Outcomes

Primary Outcome Measures

Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2011
Last Updated
November 29, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01444209
Brief Title
Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas
Official Title
Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Failure to accrue
Study Start Date
September 30, 2011 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Macroadenoma
Keywords
pituitary gland

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation Therapy
Arm Type
Experimental
Arm Description
Interstitial Radioactive Iodine Implants
Intervention Type
Radiation
Intervention Name(s)
Iodine Implants
Intervention Description
Interstitial Radioactive Iodine Implants
Primary Outcome Measure Information:
Title
Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change of the Patient's Humphrey Visual Field Testing
Time Frame
5 years
Title
Potential Toxicities Associated With Interstitial Seed Placement
Time Frame
5 years
Title
Progression Free Survival
Time Frame
5 years
Title
The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes)
Time Frame
5 years
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Timmerman, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

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