Radiosurgical Hypophysectomy for Bone Metasteses Pain

NCT03377517 | Terminated Results DMC FDA Device

• 2 other identifiers: J17181IRB00158648
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

• 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.

  Post treatment day 10

Secondary Outcomes (3)

• Participants With Reduction in Opioid Utilization Following Radiosurgical Hypophysectomy

  Approximately 28 weeks following completion of radiosurgical hypophysectomy

• Participants With Radiation Induced Optic Neuropathy Following Radiosurgical Hypophysectomy

  Approximately 28 weeks following completion of radiosurgical hypophysectomy

• Participants With Radiation-associated Acute and Long Term Neurologic Toxicity

  Approximately 28 weeks following completion of radiosurgical hypophysectomy

Study Arms (1)

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.

Radiation: radiosurgical hypophysectomy

Interventions

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.

Research Treatment Plan for all study enrollees

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Accuray Incorporated: collaborator

Study Sites (1)

The Sidney Kimmel Comprehsensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Results Point of Contact

• Title: Kristin Redmond, MD
• Organization: Johns Hopkins University

kjanson3@jhmi.edu

410-955-6980

Study Officials

• Kristin Redmond, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: December 8, 2017
• First Posted: December 19, 2017
• Study Start: May 8, 2018
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: September 17, 2026
• Results First Posted: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)