Bone MetastasesNCT03377517
Radiosurgical Hypophysectomy for Bone Metasteses Pain
A study testing radiosurgical hypophysectomy in people with Bone Metastases, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bone Metastases
- What is being tested?
- radiosurgical hypophysectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 15 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologic proof of malignancy
- Radiographic evidence of bone metastases
- Intractable pain uncontrolled by opioids, medical management, injections/ablation or surgical intervention that would be difficult to address with conventional radiation therapy or other standard options and is limiting the patient's function and quality of life. Intractable pain will be defined as a visual analogue score of at least 4.
- Definitive radiographic progression of osseous and/or visceral metastases on standard staging scans (CT, MRI, bone scan, PET scan or any other standard of care imaging) performed within the last 3 months in spite of standard oncologic interventions and/or inability to tolerate standard oncologic interventions
- Life expectancy at least 4 weeks
- Age≥ 18 years
Show all 9Show fewer
- Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
- Patient must have the ability to understand and the willingness to sign a written informed consent document
- All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
Who cannot join
- Prior brain radiation
- Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment
- Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
- Malignancies being managed with curative intent
- Life expectancy <4 weeks
- The tumor amenable to curative management
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
About this study
Official title: A Pilot Study of Stereotactic Radiosurgical Hypophysectomy for Intractable Pain From Bone Metastases
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.
Read the detailed description
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.
- Conditions
- Bone Metastases
- Being tested
- radiosurgical hypophysectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiosurgical hypophysectomyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Research Treatment Plan for all study enrollees | 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. Receives: Radiation: radiosurgical hypophysectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Score range 0-10, higher score worse pain. A 2 point reduction in the worst pain severity score on the Brief Pain Index (ie: question number 3) at 4 weeks following completion of radiosurgical hypophysectomy compared to baseline will be considered as clinically meaningful decrease.
Measured: Post treatment day 10
Secondary outcomes (3)
Participants With Reduction in Opioid Utilization Following Radiosurgical Hypophysectomy
To estimate the rate of reduction in opioid utilization following radiosurgical hypophysectomy
Measured: Approximately 28 weeks following completion of radiosurgical hypophysectomy
Participants With Radiation Induced Optic Neuropathy Following Radiosurgical Hypophysectomy
To estimate the risk of radiation induced optic neuropathy following radiosurgical hypophysectomy
Measured: Approximately 28 weeks following completion of radiosurgical hypophysectomy
Participants With Radiation-associated Acute and Long Term Neurologic Toxicity
To estimate the radiation-associated acute and long term neurologic toxicity of radiosurgical hypophysectomy
Measured: Approximately 28 weeks following completion of radiosurgical hypophysectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start8 May 2018
- Primary completion15 May 2024
- Study completion15 May 2024
Why it stopped: Accrual was slower than anticipated and funding was not extended beyond original contract.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- Accuray Incorporated
- Responsible party
- Sponsor
- Investigators
- Kristin Redmond, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377517
- Sponsor's protocol ID
- J17181
- Other IDs
- IRB00158648
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2017
- Last updated
- 17 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Stereotactic Radiosurgical Hypophysectomy for Intractable Pain From Bone Metastases
- ClinicalTrials.gov ID
- NCT03377517
- Acronym / sponsor ID
- J17181
- Conditions
- Bone Metastases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual was slower than anticipated and funding was not extended beyond original contract.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Accuray Incorporated
- Study start
- 8 May 2018 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Posted 16 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Research Treatment Plan for all study enrollees | Experimental | Radiation: radiosurgical hypophysectomyPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cytologic proof of malignancy
- Radiographic evidence of bone metastases
- Intractable pain uncontrolled by opioids, medical management, injections/ablation or surgical intervention that would be difficult to address with conventional radiation therapy or other standard options and is limiting the patient's function and quality of life. Intractable pain will be defined as a visual analogue score of at least 4.
- Definitive radiographic progression of osseous and/or visceral metastases on standard staging scans (CT, MRI, bone scan, PET scan or any other standard of care imaging) performed within the last 3 months in spite of standard oncologic interventions and/or inability to tolerate standard oncologic interventions
- Life expectancy at least 4 weeks
Key exclusion criteria (6 listed)
- Prior brain radiation
- Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment
- Isolated localized pain amenable to focal radiation therapy, or pain well controlled by opioids, medical management, injections/ablation or surgical intervention
- Malignancies being managed with curative intent
- Life expectancy <4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiosurgical hypophysectomyPatients 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. | Radiation | Research Treatment Plan for all study enrollees |
Primary outcome
Change in Intensity of Bone Pain
Time frame: Post treatment day 10
To estimate the rate of clinically meaningful decrease in diffuse osseous pain following radiosurgical hypophysectomy at 4 weeks following completion of radiosurgical hypophysectomy. Score range 0-10, higher score worse pain. A 2 point reduction in the worst pain severity score on the Brief Pain Index (ie: question number 3) at 4 weeks following completion of radiosurgical hypophysectomy compared to baseline will be considered as clinically meaningful decrease.
3 secondary outcomes
Participants With Reduction in Opioid Utilization Following Radiosurgical Hypophysectomy
Time frame: Approximately 28 weeks following completion of radiosurgical hypophysectomy
Participants With Radiation Induced Optic Neuropathy Following Radiosurgical Hypophysectomy
Time frame: Approximately 28 weeks following completion of radiosurgical hypophysectomy
Participants With Radiation-associated Acute and Long Term Neurologic Toxicity
Time frame: Approximately 28 weeks following completion of radiosurgical hypophysectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Bone Metastases
RecruitingObservational study
Dual Energy CT - a Tool for Delineation of Tumor and Organs at Risk in Radiotherapy
Brain Metastases, Bone Metastases
Not yet recruiting
Peri-Transplant Gecacitinib in Patients With Myelofibrosis Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Myelofibrosis, Primary Myelofibrosis (PMF)
RecruitingObservational study
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Neoplasms, Cancer
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
RecruitingPhase 1
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Redmond, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiosurgical hypophysectomy in people with Bone Metastases, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intensity of Bone Pain (time frame: Post treatment day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.