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.
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.
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
- The establish subjective risk classification of debulking surgery in term of tumour vascularity
- To subjectively evaluate efficacy of preoperative embolization
- 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.
- Conditions
- Spinal Metastases, 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 group | Role | What they receive |
|---|---|---|
| Embolized patients | subjects 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.
estimated blood loss during surgery
blood lose in debulking spinal surgery
Measured: 24 hours
Secondary outcomes (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.
- First posted4 Aug 2020
- Study start18 Aug 2020
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen-Heng Lin, MD, Principal investigator, National Taiwan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using CT-DSA With Deformable Registration Technique to Predict Efficacy in Preoperative Embolization for Spinal Metastasis
- ClinicalTrials.gov ID
- NCT04497051
- Acronym / sponsor ID
- 202001028RINB
- Conditions
- Spinal Metastases, Surgery
- Keywords
- vertebra, embolization, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- The establish subjective risk classification of debulking surgery in term of tumour vascularity
- To subjectively evaluate efficacy of preoperative embolization
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolized patients | – | Diagnostic Test: CT-DSAsubjects receiving preoperative embolization for aggressive spinal debulking surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with clinical diagnosis for thoracolumbar vertebral malignancy who can receive preoperative emoblization
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Age less than 20 year old
- Woman in pregnancy or breast feeding
- Serious allergic reaction to contrast medium
- Instable neurological condition warrant urgent operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-DSACTA before and after embolization | Diagnostic test | Embolized patients |
Primary outcome
estimated blood loss during surgery
Time frame: 24 hours
blood lose in debulking spinal surgery
1 secondary outcome
transfusion amount
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Heng Lin, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
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.