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NCT04218617 · ClinicalTrials.gov registry record · Phase 2
Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
A Phase 2 study of Spine Metastases and Spine Stereotactic Radiosurgery (sSRS), sponsored by Case Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT04218617: Recruiting Phase 2 study of Spine Metastases and Spine Stereotactic Radiosurgery (sSRS), sponsored by Case Comprehensive Cancer Center.
NCT04218617 is a Phase 2 study of Spine Metastases and Spine Stereotactic Radiosurgery (sSRS) that is actively recruiting participants, run by Case Comprehensive Cancer Center. The registered enrollment target is 130 participants, below the 474-participant average among 7 other Spine Metastases trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04218617, a Phase 2 study of Spine Metastases and Spine Stereotactic Radiosurgery (sSRS), is actively recruiting participants, sponsored by Case Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.
Primary Outcome
6-month cumulative incidence of Vertebral Compression Fracture (VCF) associated with single- and two-fraction sSRS Each treated vertebra will be assessed individually for VCF during radiologic follow-up
Conditions Studied
Interventions
- DEVICE Diagnostic MRI
- DEVICE Planning MRI
- OTHER Simulation CT
- OTHER QOL assessment
- OTHER Brief pain inventory (BPI)
Study Locations (1)
Ohio
- Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2020-02-07 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What NCT04218617 shows while recruiting
NCT04218617 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 474-participant average among 7 other Spine Metastases trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Spine Metastases appearing as the primary indexed condition, and to 5 interventions - of which Diagnostic MRI is the first listed.
NCT04218617 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04218617 about?
NCT04218617 is a clinical study titled "Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases". Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be t...
What is the current status of trial NCT04218617?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2020-02-07. Estimated completion is 2026-10.
What conditions does trial NCT04218617 study?
This clinical trial studies the following conditions: Spine Metastases, Spine Stereotactic Radiosurgery (sSRS).
What interventions are being tested in trial NCT04218617?
The interventions under investigation include: Diagnostic MRI (DEVICE), Planning MRI (DEVICE), Simulation CT (OTHER), QOL assessment (OTHER), Brief pain inventory (BPI) (OTHER).
Who is sponsoring clinical trial NCT04218617?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04218617 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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