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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00158648 | Other Identifier | JHM IRB |
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Accrual was slower than anticipated and funding was not extended beyond original contract.
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| Name | Class |
|---|---|
| Accuray Incorporated | INDUSTRY |
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This research is being done to see if a delivery of a single high dose of radiation therapy to a small area of the pituitary gland and pituitary stalk in a highly precise manner may be helpful in reducing intractable pain from bone metastases.
Although not currently standard of care, small series suggest both safety and efficacy of radiosurgical hypophysectomy in reducing cancer pain from bone metastases. In spite of the demonstrated feasibility in meeting normal tissue constraints and preliminary data suggestive of both safety and efficacy, radiosurgical hypophysectomy is rarely performed in clinical practice, and many radiation oncologists are not even aware of its potential to reduce intractable cancer pain. This is likely because, to date, well-designed prospective studies have not been performed to further explore both the safety and efficacy of the intervention. This single arm pilot study is designed to fill that void. If successful, the investigators plan to utilize the data to support the proposal of a larger scale follow-up clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ResearchTreatment Plan | Experimental | Patients will be treated to a dose of 150 Gy in a single fraction. All patients will undergo CT simulation with 1 mm slices as well as MRI simulation including at least high resolution 1 mm slice T1 weighted MRI. They will be treated in a supine position using an aquaplast mask system for immobilization. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiosurgical hypophysectomy | Radiation | Patients will be treated to a dose of 150 Gy in a single fraction. All patients will undergo CT simulation with 1 mm slices as well as MRI simulation including at least high resolution 1 mm slice T1 weighted MRI. They will be treated in a supine position using an aquaplast mask system for immobilization. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intensity of Bone Pain | To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy at 4 weeks following completion of radiosurgical hypophysectomy | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of change of disease spread | To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy | Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of Change of Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Redmond, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 2, 2026 |
Patients will be treated to a dose of 150 Gy in a single fraction. All patients will undergo CT simulation with 1 mm slices as well as MRI simulation including at least high resolution 1 mm slice T1 weighted MRI. They will be treated in a supine position using an aquaplast mask system for immobilization.
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To estimate the rate of clinically meaningful increase in patient reported quality of life following radiosurgical hypophysectomy |
| Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of change in opioid use | To estimate the rate of reduction in opioid utilization following radiosurgical hypophysectomy | Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of biochemical endocrinopathy | To estimate the rate of biochemical endocrinopathy following radiosurgical hypophysectomy | Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of change of optic nueropathy | To estimate the risk of radiation induced optic neuropathy following radiosurgical hypophysectomy | Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of change of neurologic toxicity | To estimate the radiation-associated acute and long term neurologic toxicity of radiosurgical hypophysectomy | Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of change of insipidus diabetes | To estimate the rate of diabetes insipidus following radiosurgical hypophysectomy | Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of change in costs | To estimate the cost effectiveness of radiosurgical hypophysectomy | Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of change of cortisol | To estimate the relationship between pain response and cortisol levels | Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of change of pain with respect to hormones | To estimate the rate of pain response in hormonally active and non-hormonally active tumors | Up to 100 weeks following completion of radiosurgical hypophysectomy |
| Rate of change of pain with respect to morphine | To estimate the rate of pain response in morphine sensitive and morphine insensitive tumors | Up to 100 weeks following completion of radiosurgical hypophysectomy |