RAD 1501: A Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

RAD 1501: A Phase II Trial of Virtual Cone Trigeminal Neuralgia Radiosurgery

To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment.

Study Overview

• Status: Active, not recruiting
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Device: Unframed Virtual Cone; Radiation: 80 Gy Radiation

Detailed Description

To determine the feasibility of frameless Virtual Cone trigeminal neuralgia radiosurgery at a single institution prior to multi-institutional enrollment. To measure pain relief after Virtual Cone radiosurgery utilizing the Barrow Neurologic Institute Pain Intensity Score (BNI).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laronica K. Conway; Email: laronicaconway@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Hazelrig-Salter Radiation Oncology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with trigeminal neuralgia pain that is not well controlled despite medical management (BNI 4 OR BNI 5)
• Patients must have an ECOG status of 0, 1, or 2
• Patients must be at least 18 years of age
• Life expectancy must be greater than 12 months
• MRI of brain within prior 12 months to confirm lack of other causes of facial pain
• All patients must be given written informed consent

Exclusion Criteria:

• Patients who have had prior brain radiosurgery or therapeutic radiation therapy to the pons
• Patients with atypical trigeminal neuralgia or headache pain syndromes
• Patients with pain associated with multiple sclerosis or base of skull tumor
• Patients with medical contra-indications to MR imaging (e.g. pacemaker)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 80 Gy Radiation & Unframed Virtual Cone; 80 Gy Virtual Cone Radiosurgery unframed (face mask)

Device: Unframed Virtual Cone; A face mask (unframed) will be placed over the patient's face to keep their head from moving during the procedure. This will allow for very precise targeting. During the procedure, the study doctor will also confirm the exact location that needs to be treated using x-rays and optical imaging cameras. The face mask (unframed) will hold the patient's head to prevent it from moving and to focus the x-rays and aim them on the painful nerve in the patient's brain. For most patients, the actual time on the radiosurgery treatment machine is in the range of 30 to 60 minutes. The face mask (unframed) will be removed after the treatment.; Other Names: Face Mask; Radiation: 80 Gy Radiation; Other Names: Radiosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Frameless Virtual Cone Trigeminal Neuralgia Radiosurgery as assessed by number of participants that completed treatment		3 Month Follow-Up Visit
The mean of Barrow Neurologic Institute Pain Intensity Score (BNI) (pain relief score) between the two arms.	Pain Relief Score designed to assess trigeminal neuralgia associated pain. It ranges from "I" being "no trigeminal pain, no medication" to "V" being "severe pain/no pain relief".	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with treatment-related adverse events	Based on the assessments of the patient and the responses provided by the patient in questionnaires, we will assess acute and late neurologic toxicities. All adverse events/toxicities will be assessed with the utilization of CTCAE v.4.0.	1 Year
Mean of Quality of Life Scores as measured by SF-36 Questionnaire	Quality of Life (QOL) will be measured by SF-36. This questionnaire consists of 36 questions (items) measuring physical and mental health in relation to 8 health concepts: physical functioning, bodily pain, role of limitations due to physical health problems, role of limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perception. All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are set at 0 and 100, respectively.	1 Year
Patient Satisfaction Scores	3 months following the completion of radiosurgery, the patient will be asked the following two questions: 1) Would you have the radiosurgery procedure again? 2) Would you recommend it to friends and family?	3 Month Follow-Up Visit

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: John Fiveash, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: November 16, 2015
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimated): March 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: radiosurgery (RS); trigeminal neuralgia (TGN)
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: IRB-150608005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO