Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001417
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Direct Injection of Alcohol for the Treatment of Spinal Tumors
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of the Efficacy of Direct Intratumoral Injection of Absolute Ethanol in Treating Symptomatic Spinal Tumors
Status:
COMPLETED
Status Verified Date:
2002-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Tumors of the spine can be described as primary meaning that the tumor originated from cells normally found in the spine or metastatic cells from another area of the body that have spread to the spine Metastatic tumors are more common than primary tumors Tumors of the spine can press against the spinal cord and interfere with information traveling down from the brain to the nerves of the spinal cord As a result patients with spinal tumors can suffer from loss of movement and sensation within areas of the body below the tumor In addition tumors of the spine are typically painful conditions
Presently the treatment of choice for spinal tumors is radiation therapy However many tumors of the spine become resistant to radiation therapy In addition because the spinal cord is often so close to the tumor it can be damaged by the radiation
Absolute 100 ethanol is commonly known as alcohol It is the same kind of alcohol found in alcoholic beverages When pure alcohol is injected directly into a tumor it can destroy cells and blood vessels Because of this feature researchers would like to test the effectiveness of alcohol in treating patients with spinal tumors
Researchers believe that intratumoral ethanol injection is a treatment worth studying more closely because it is minimally invasive has been proven to be an effective treatment for other types of metastatic tumors can be used repeatedly and does not interfere with other treatments such as surgery
In addition to testing the effectiveness of intratumoral ethanol injection this study will attempt to determine the causes of pain associated with spinal tumors
Presently the treatment of choice for spinal tumors is radiation therapy However many tumors of the spine become resistant to radiation therapy In addition because the spinal cord is often so close to the tumor it can be damaged by the radiation
Absolute 100 ethanol is commonly known as alcohol It is the same kind of alcohol found in alcoholic beverages When pure alcohol is injected directly into a tumor it can destroy cells and blood vessels Because of this feature researchers would like to test the effectiveness of alcohol in treating patients with spinal tumors
Researchers believe that intratumoral ethanol injection is a treatment worth studying more closely because it is minimally invasive has been proven to be an effective treatment for other types of metastatic tumors can be used repeatedly and does not interfere with other treatments such as surgery
In addition to testing the effectiveness of intratumoral ethanol injection this study will attempt to determine the causes of pain associated with spinal tumors
Detailed Description:
Although radiation therapy is currently the treatment of choice for most spinal metastases radioresistant and recurrent neoplasms remain therapeutic dilemmas Because of the debility and shortened life expectancy of patients with spinal metastases treatment that minimizes blood loss convalescence and immobility is critical The effectiveness and safety of intratumoral injection of absolute ethanol in eradicating vertebral hemangiomas and hepatic metastases suggests that intratumoral ethanol injection may also be effective in treating vertebral metastases Since most spinal metastases can now be diagnosed with MRI before they produce spinal instability it may be possible to treat them with direct ethanol infusion while preserving spinal stability Direct ethanol infusion may prove especially useful in treating symptomatic patients who have received maximal tolerable radiation doses to the spinal cord Unlike radiation which is limited by total radiation dosage and intraarterial alcohol which precludes multiple treatments by occluding the feeding arteries intratumoral ethanol injection can be repeated as necessary to obliterate residual tumor The potential neurotoxic effects of ethanol can be avoided by using CT-guidance to position the needle by monitoring a test injection with contrast and by injecting ethanol slowly and in small volumes Intratumoral injection of absolute ethanol warrants a clinical trial because it is minimally invasive has been effective in treating peripheral metastases can be used repeatedly and does not preclude other types of treatments such as open surgery
As well as testing the therapeutic efficacy of intratumoral ethanol for spinal metastasis this protocol seeks to elucidate the pathophysiology of pain from spinal metastasis Correlation of changes in pain with changes in tumor size and tumor pressure pre- and post-ethanol injection should indicate the relationship of pain to tumor size and pressure
A group of 11 patients with vertebral hemangiomas has been treated with intratumoral ethanol at the NIH This protocol will accrue patients with vertebral hemangiomas who require treatment with intratumoral ethanol and will continue the post-treatment evaluation of patients previously treated with intratumoral ethanol at the NIH
As well as testing the therapeutic efficacy of intratumoral ethanol for spinal metastasis this protocol seeks to elucidate the pathophysiology of pain from spinal metastasis Correlation of changes in pain with changes in tumor size and tumor pressure pre- and post-ethanol injection should indicate the relationship of pain to tumor size and pressure
A group of 11 patients with vertebral hemangiomas has been treated with intratumoral ethanol at the NIH This protocol will accrue patients with vertebral hemangiomas who require treatment with intratumoral ethanol and will continue the post-treatment evaluation of patients previously treated with intratumoral ethanol at the NIH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 94-N-0158 | None | None | None |