Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04497051 |
| Other study ID # |
202001028RINB |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 18, 2020 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
National Taiwan University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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
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.
