Evaluation of Spinal Metastatic Tumour for Aggressive Spinal Sugery by Dual Energy CT

NCT03631095 | Completed

• 1 other identifier: 201805119RINA
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Metastatic vertebral disease is a major hazard for oncological patients because the performance and life quality will substantially deteriorate if presence of neoplastic compression. And the subsequent treatment and overall survival will be dismal. Restoration of vertebral stability and prevention of neurological deterioration are treatment goal. Surgical treatment is an important and effective method for metastatic spinal disease. For aggressive surgical method, long-term control is better. However, massive bleeding is often encountered in this surgery, and preoperative evaluation is very important for successful operation. Imaging play major role in this tasks. MRI, angiography, and nuclear medicine studies are common modalities, but take longer time and are often suboptimal. Dual-energy CT has the ability to detect contrast medium enhancement in osseous structure. It therefore is a potential optimal tool in the evaluate the metastatic spinal malignancy. It also own advantage of rapid scanning, optimal resolution, and easy reformatting.In this study, we intend to use this tool to establish the imaging biomarker for tumoural vascularity, to compare its performance with other modalities, and to investigate its optimal imaging condition, which will bring valuable information for treatment planning for aggressive spinal surgery before metastatic disease.

Conditions

Spinal Metastases

Outcome Measures

Primary Outcomes (1)

• overall survivial

  overall survival after operation

  5 year

Secondary Outcomes (1)

• blood loss

  one week

Other Outcomes (1)

• local recurrence

  5 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with vertebral metastasis for aggressive spinal surgery

You may qualify if:

• Patient with clinical suspicious for vertebral metastasis and operation is a treatment option
• Life expectancy more than 6 months
• Serum creatinine less than 2.0 mg/dL

You may not qualify if:

• Age less than 20 year old
• Woman in pregnancy or breast feeding
• Serious allergic reaction to contrast medium

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2018
• First Posted: August 15, 2018
• Study Start: August 10, 2018
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: February 4, 2021

Record last verified: 2020-03

Locations

TW (1)