Pituitary Macroadenoma
Conditions
Keywords
pituitary gland
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.
Interventions
RADIATIONIodine Implants
Interstitial Radioactive Iodine Implants
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change of the Patient's Humphrey Visual Field Testing | 5 years |
| Potential Toxicities Associated With Interstitial Seed Placement | 5 years |
| Progression Free Survival | 5 years |
| The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes) | 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 | 5 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiation Therapy Interstitial Radioactive Iodine Implants
Iodine Implants: Interstitial Radioactive Iodine Implants | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Radiation Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.
Time frame: 12 months
Population: No data collected
Secondary
Change of the Patient's Humphrey Visual Field Testing
Time frame: 5 years
Population: Data were not collected
Secondary
Potential Toxicities Associated With Interstitial Seed Placement
Time frame: 5 years
Population: No data collected
Secondary
Progression Free Survival
Time frame: 5 years
Population: No data collected
Secondary
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
Population: No data collected
Secondary
The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes)
Time frame: 5 years
Population: No data collected