Medical Data Collection for the Evaluation of Radiofrequency Ablation and Cement Augmentation for the Treatment of Secondary Metastases to the Spine

April 10, 2023 updated by: M.D. Anderson Cancer Center

A Single-Center Retrospective Study Evaluating Radiofrequency Ablation and Cement Augmentation for the Treatment of Secondary Metastases to the Spine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the use of radiofrequency ablation and cement augmentation for the treatment of secondary metastases to the spine.

OUTLINE:

Patients' medical data is collected retrospectively.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (data collection)
Patients' medical data is collected retrospectively.
Other: Electronic Health Record Review
Medical data is collected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: Up to 3 years
Results will be compared with data available from other published literature.
Up to 3 years
Clinical success
Time Frame: Up to 3 years
Results will be compared with data available from other published literature.
Up to 3 years
Complication rates
Time Frame: Up to 3 years
Results will be compared with data available from other published literature.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2020

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

February 8, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 12, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1012 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-00607 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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