- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04751422
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
-
-
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.
|
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
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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