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Spinal MetastasesNCT03631095

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

An observational study of Spinal Metastases, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Spinal Metastases
How many people
61 participants
Where
1 siteTaiwan
Study dates
10 Aug 2018to 29 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with vertebral metastasis for aggressive spinal surgery

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

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.

Read the detailed description

Spinal metastasis is the leading course of vertebral malignancy. It cause neoplastic spinal cord compression and neurological deficit. The treatment strategy depend on the pathological type, performance status, and life expectancy.(1, 2) The goal of treatment is to avoid neurological deterioration, to keep functional life, and to control bone pain. Because disease cure is rarely the treatment goal in the circumstance of metastatic disease, the treatment strategy involve multidisciplinary approaches. When evidence of neoplastic compression, local oncological treatment is often needed to preserve neurological function and to restore vertebral column stability. Radiation therapy can be applied for some radiosensitive tumour, but surgery is often required to meet above goal. Simple decompression and fixation is often applied, but the long-term control rate is suboptimal. Aggressive spinal surgery has relative longstanding effect to maintain neurological and oncological outcome in selective patients. (3)

Aggressive spinal surgery, including extensive corpectomy, vertebrotrectomy, and even spondylectomy, however, is a massive procedure and may result in large amount, sometime life-threatening blood loss. To achieve better surgical outcome and decrease complication, preoperative evaluation needs understanding the detailed skeleton and vascular anatomy. The status of vertebral column stability, extent of tumour involvement, condition of neurological tissue, and vascularity of the tumoural tissue, are all important in determination of the surgical planning and outcome. In many circumstances, preoperative embolization is often required to control blood loss as well.(4, 5) Imaging plays major role in the above information related to the surgical decision and planning.

Current preoperative imaging evaluation include MRI, angiography, bone scan and PET. (6) The MRI is paramount in the spinal imaging. It provides outstanding soft tissue differentiation, which usually depicting the abnormal tumoural tissue clearly. Therefore, MRI stands central role in the surgical evaluation. Nevertheless, in real world, many patients are frail to tolerate lengthy MRI study period, and the MR imaging quality is often suboptimal. For vascular survey, angiography is capable to demonstrate spinal artery and tumour vascularity. Since its relative invasiveness, it is only reserved for patients when preoperative embolization is required or detection of spinal artery is warranted. And because the angiography study for tumour involves selective catheterization of separate segmental artery, the global evaluation of tumoural tissue is not possible. As for nuclear medicine studies, including bone scan and PET, they are highly sensitive and very convenient in detecting multifocal disease. But they are relative non-specific for variable pathology and the spatial resolution is not adequate for surgical evaluation. Therefore, they provide less information when diagnosis has been established.

CT is an important imaging tool for spinal disease. Because of its rapid acquisition, adequate resolution, and easy reformatting, it is optimal for intolerable patients. (7) Nevertheless, osseous structure is extremely radiopaque, evaluation of tumoural enhancement in vertebrae is not easy. It is reserved in special condition, such as detection of vascular structure for embolization and surgery. Recently commercialized dual-energy CT (DECT) can meet the prior result of conventional CT with added value. (8) It uses different energy level simultaneously to image the object. Therefore, optimal bony removal and contrast-noise-ratio can be expected.(9, 10) In spinal disease, it has been used in the detection of marrow edema and compression fracture. (9, 11) On the other hand, material-specific information can be obtained, quantitative evaluation of tumoural enhancement by contrast medium is possible. (12) Along with imaging post-processing technique, DECT can highlight the tumoural part in the background of hyperdense bone. (13) DECT is a promising tool to study the vascularity of the metastatic vertebral tumour. This information is valuable for the surgeon in the decision making and planning for the operation.

We intend to use the dual energy CT in the preoperative evaluation of the vertebral metastasis before aggressive surgery. The research potential and purposes are manifold. First, we want to establish imaging biomarker for tumoural vascularity. Many different enhancement parameters as potential candidate will be measured. Second, we intend to establish one-stop imaging method; therefore, we will compare the diagnostic performance with other imaging modalities. Third, the optimal imaging parameter in the evaluation of bony lesion will be investigated, and many image technical condition will be studied.

Purpose:

  1. To establish the quantitative imaging biomarker for vascularity in metastatic vertebral tumour
  2. To obtain the optimal DECT scanning parameter and reformatting method in vertebral osseous tumour
  3. To provide detailed anatomical information for embolization and surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survivial

    overall survival after operation

    Measured: 5 year

Secondary outcomes (1)
  1. blood loss

    during operation

    Measured: one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2018
  2. Study start10 Aug 2018
  3. Primary completion29 Oct 2020
  4. Study completion29 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03631095
Sponsor's protocol ID
201805119RINA
Status last verified
Mar 2020
First submitted
12 Aug 2018
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Metastases, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survivial (time frame: 5 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.

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