NCT04751422

Brief Summary

This study collects data on the use of radiofrequency ablation and cement augmentation for the treatment of cancer that has spread to the spine (metastases to the spine). Radiofrequency ablation with cement augmentation is a useful approach for the treatment of secondary metastasis to the spine. Information collected in this study may help doctors to learn the effectiveness of this therapy, and may help to evaluate optimal technique, appropriate patient selection, and management of complications.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2.9 years

First QC Date

February 8, 2021

Last Update Submit

April 10, 2023

Conditions

Metastatic Malignant Neoplasm in the Spine

Outcome Measures

Primary Outcomes (3)

  • Technical success

    Results will be compared with data available from other published literature.

    Up to 3 years

  • Clinical success

    Results will be compared with data available from other published literature.

    Up to 3 years

  • Complication rates

    Results will be compared with data available from other published literature.

    Up to 3 years

Study Arms (1)

Observational (data collection)

Patients' medical data is collected retrospectively.

Other: Electronic Health Record Review

Interventions

Electronic Health Record ReviewOTHER

Medical data is collected

Observational (data collection)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent radiofrequency ablation with cement augmentation at the Department of Interventional Radiology at MD Anderson Cancer Center (MDACC) between 1/1/2017 and 9/26/2020

You may qualify if:

  • Patients who underwent radiofrequency ablation with cement augmentation at the Department of Interventional Radiology at MD Anderson Cancer Center (MDACC) between 1/1/2017 and 9/26/2020

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

Study Officials

  • Rahul A Sheth

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2021

First Posted

February 12, 2021

Study Start

November 13, 2020

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

US(1)