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Spinal MetastasesNCT04497051

CT-DSA Evaluation of Embolization in Debulking Spinal Surgery

An observational study of Spinal Metastases and Surgery, 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

Vertebra is one of the most common site of metastatic disease, which may cause severe pain or neurological deficit. Decompressive surgery or radiation therapy are of limited efficacy and recurrence is very likely. Debulking surgery usually has better local control and survival benefit. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Spinal Metastases, Surgery
What is being tested?
CT-DSA
How many people
48 participants
Where
1 siteTaiwan
Study dates
18 Aug 2020to 31 Mar 2023
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
  • Adult, Older adult

Study population: Patient with clinical diagnosis for thoracolumbar vertebral malignancy who can receive preoperative emoblization

Who may be able to join

  • Patient with clinical diagnosis for thoracolumbar vertebral primary or metastatic malignancy
  • Eligible for aggressive spinal surgery, including debulking and en bloc spondylectomy
  • Life expectancy more than 6 months
  • Serum creatinine less than 1.5 mg/dL

Who cannot join

  • Age less than 20 year old
  • Woman in pregnancy or breast feeding
  • Serious allergic reaction to contrast medium
  • Instable neurological condition warrant urgent operation

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: Using CT-DSA With Deformable Registration Technique to Predict Efficacy in Preoperative Embolization for Spinal Metastasis

Vertebra is one of the most common site of metastatic disease, which may cause severe pain or neurological deficit. Decompressive surgery or radiation therapy are of limited efficacy and recurrence is very likely. Debulking surgery usually has better local control and survival benefit. However, debulking surgery often accompany with massive blood loss, which may cause hemorrhagic shock or death. It is known that intraoperative blood loss is associated with tumoral vascularity. However, there is current no objective method to evaluate vascularity status. On the other hand, preoperative embolization is considered as major method to decrease blood loss. There is also objective method to evaluate the embolization effect. By our innovative dual energy computed tomography angiography - digital subtraction angiography (CT-DSA), the tumoral vascularity status and embolization effect of spinal tumor can be objectively assessed. We aim to utilize CT-DSA to investigate spinal tumor, in a hope to find out correlation of vascularity status, embolization method, and surgical outcome, which can help individual disease status and tailored treatment decision.

Key word: spine/embolization/computed tomography

Read the detailed description

Vertebral osseus metastasis, can cause neoplastic spinal cord compression and neurological deficit. The treatment strategy depend on the pathological type, performance status, and life expectancy. The goal of treatment is to avoid neurological deterioration, to keep functional life, and to control bone pain. Treatment strategy involve multidisciplinary approaches between spinal surgeon, medical and radiation oncologist, and radiologist. When presence of acute neurological deterioration or intractable pain due to neoplastic compression or vertebral instability, surgical approach is often warranted. In term of surgical approach, simple decompression and fixation is often applied, but the long-term control rate is suboptimal. Aggressive spinal surgery, including extensive debulking surgery or spondylectomy, has relative longstanding effect to maintain neurological and oncological outcome.

Despite relative good outcome of aggressive spinal surgery, it is a relative massive procedure in which life-threatening blood loss commonly occur. To achieve better surgical outcome and decrease complication, preoperative embolization is suggested to control blood loss . The procedure is performed by an interventional radiologist to deliver embolic agent into vascular pedicles of target vertebra, in hope to achieve optimal devascularization of the tumour. The concept is simple and the similar procedure has been performed thousands of times in the world. However, its efficacy and utilization are not yet proven by clinical trials. When and how to perform this procedure largely depends on experience of operating interventional radiologist.

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. Nevertheless, osseous structure is extremely radiopaque, evaluation of tumoral enhancement in vertebrae is not easy. Nevertheless, the enhancement of osseous tumour can be evaluated with advanced subtraction reformatting technique. The technique is similar to digital subtraction angiography (DSA) of catheter angiography, and we call it CT-DSA image. As compared with traditional catheter-based DSA, CT-DSA has following additional advantages: 1) non-invasiveness; 2) non-selective enhancement of the target; 3) allowing multiplanar reformatting and additional post-processing and quantification. The tool is very versatile to investigate the vascularity of the vertebral neoplasm. In our earlier result, we found the CT-DSA has good correlation with DSA in vascularity assessment, suggestive of its utilization in pre-operative and pre-embolization evaluation of spinal tumour. It can be used in semi-quntitative and quantitative fashion.

Traditionally, the efficacy of embolization is determined by surgical outcome, usually with gold standard of blood loss. However, blood loss is determined by many different factors, including tumor volume, surgical technique, and other anatomical factors. Using CT-DSA, evaluation of the embolization effect directly is possible. As the study can be repeated after embolization, the interval change can be observed with objective measurement.

In summary, using CT-DSA, it is possible to evaluate the vascularity of the osseous tumour and efficacy of devascularization after embolization before surgery. We can therefore design study to test efficacy of different intervention strategy, and find out the more beneficial indication, which can incorporate into clinical workflow and help patients.

Purpose

  1. The establish subjective risk classification of debulking surgery in term of tumour vascularity
  2. To subjectively evaluate efficacy of preoperative embolization
  3. To design appropriate clinical workflow in management of patient with vertebral malignancy

Importance Vertebrae is 3rd most common site of metastatic malignancy, and is usually warrant aggressive spinal surgery. Since preoperative embolization is commonly done in this patient, it needs subjective tool to assess its efficacy and clear indication. By using CT-DSA, there is potential to provide tailored strategy of patient management before surgery.

Being tested
CT-DSA
Keywords
vertebra, embolization, surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT-DSADiagnostic test

    CTA before and after embolization

Study groups in NCT04497051
Study groupRoleWhat they receive
Embolized patientssubjects receiving preoperative embolization for aggressive spinal debulking surgery
Receives: Diagnostic Test: CT-DSA

What is being measured

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

  1. estimated blood loss during surgery

    blood lose in debulking spinal surgery

    Measured: 24 hours

Secondary outcomes (1)
  1. transfusion amount

    perioperative blood transfusion

    Measured: 24 hours

Timeline

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

  1. First posted4 Aug 2020
  2. Study start18 Aug 2020
  3. Primary completion31 Mar 2023
  4. Study completion31 Mar 2023

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04497051
Sponsor's protocol ID
202001028RINB
Status last verified
Mar 2023
First submitted
30 Jul 2020
Last updated
24 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Metastases and Surgery, 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 4 inclusion and 4 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 24 May 2024. 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?

estimated blood loss during surgery (time frame: 24 hours). 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 24 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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