HemangiomaNCT00001417
Direct Injection of Alcohol for the Treatment of Spinal Tumors
An observational study of Hemangioma and Neoplasm Metastasis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemangioma, Neoplasm Metastasis, Spinal Neoplasm
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1994to May 2002
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patients must have a vertebral tumor documented by MRI.
Vertebral height must be at least 50 percent of adjacent vertebrae.
Patients must be symptomatic from their spinal tumor. Treatment attempts to reduce the size of, or eliminate, their tumors and to relieve their symptoms. The treatment of the vertebral tumor must be indicated based on the patient's condition.
Prior surgical or radiation therapy for the vertebral tumor will not result in exclusion from the study if there is radiographic evidence of tumor and there is evidence of persistent local pain, epidural compression, or neurological deterioration related to the vertebral tumor.
The patient must be able to comprehend the risks of the therapy and must be able to give informed consent.
Pregnancy will exclude participation due to the radiation exposure involved in this protocol.
Bleeding disorders will exclude a patient from the protocol unless the disorder can be corrected prior to treatment.
Patients must have no contraindications to MRI scanning.
Patients undergoing ethanol injection in the x-ray department must be able to lay prone for at least one hour with intravenous sedation and analgesia.
Patients whose tumors have not responded to radiation therapy will be candidates for ethanol infusion.
Patients with tumors in areas that have received maximal radiation doses to the spinal cord will be candidates for ethanol infusion.
Patients whose poor general condition precludes open surgery will be candidates for ethanol infusion.
Patients who wish to avoid the morbidity and potential mortality of open surgery will be candidates for ethanol injection.
Patients with radioresistant tumors such as melanoma or prostate carcinoma are candidates for ethanol infusion even if they have not undergone prior irradiation.
Patients with radiation-sensitive spinal tumors such as breast, kidney, and lung carcinoma, lymphoma, myeloma, Ewing's sarcoma, neuroblastoma, seminoma will not be entered into the protocol unless their tumors have either responded to radiation or lie at spinal cord levels that have already received maximal tolerable radiation doses.
Patients with less than a 2 month life expectancy will be excluded.
Patients with symptomatic vertebral metastases at more than 3 spinal levels will be excluded.
Patients with asymptomatic vertebral metastases will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Study of the Efficacy of Direct Intratumoral Injection of Absolute Ethanol in Treating Symptomatic Spinal Tumors
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.
Read more
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.
Read the 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.
- Conditions
- Hemangioma, Neoplasm Metastasis, Spinal Neoplasm
- Keywords
- Needle Biopsy, Computed Tomography, Magnetic Resonance Imaging, Spinal Angiography, Intratumoral Pressure, Vertebral Hemangioma, Spinal Metastasis, Absolute Ethanol, Spinal Tumor, Vertebral Tumor
- Medical subject headings
- Hemangioma, Neoplasm Metastasis, Spinal Neoplasms, Spinal Cord Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJun 1994
- Study completionMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001417
- Sponsor's protocol ID
- 940158
- Other IDs
- 94-N-0158
- Status last verified
- May 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Heiss JD, Doppman JL, Oldfield EH. Brief report: relief of spinal cord compression from vertebral hemangioma by intralesional injection of absolute ethanol. N Engl J Med. 1994 Aug 25;331(8):508-11. doi: 10.1056/NEJM199408253310804. No abstract available.
PubMed 8041416Heiss JD, Doppman JL, Oldfield EH. Treatment of vertebral hemangioma by intralesional injection of absolute ethanol. N Engl J Med. 1996 May 16;334(20):1340. doi: 10.1056/NEJM199605163342017. No abstract available.
PubMed 8609965Lonser RR, Heiss JD, Oldfield EH. Tumor devascularization by intratumoral ethanol injection during surgery. Technical note. J Neurosurg. 1998 May;88(5):923-4. doi: 10.3171/jns.1998.88.5.0923.
PubMed 9576266
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Direct Intratumoral Injection of Absolute Ethanol in Treating Symptomatic Spinal Tumors
- ClinicalTrials.gov ID
- NCT00001417
- Acronym / sponsor ID
- 940158
- Conditions
- Hemangioma, Neoplasm Metastasis, Spinal Neoplasm
- Keywords
- Needle Biopsy, Computed Tomography, Magnetic Resonance Imaging, Spinal Angiography, Intratumoral Pressure, Vertebral Hemangioma, Spinal Metastasis, Absolute Ethanol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Jun 1994
- Study completion
- May 2002
- First posted
- 4 Nov 1999 (estimated)
- 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.
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.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 8041416Heiss JD, Doppman JL, Oldfield EH. Brief report: relief of spinal cord compression from vertebral hemangioma by intralesional injection of absolute ethanol. N Engl J Med. 1994 Aug 25;331(8):508-11. doi: 10.1056/NEJM199408253310804. No abstract available.
- Background: PubMed 8609965Heiss JD, Doppman JL, Oldfield EH. Treatment of vertebral hemangioma by intralesional injection of absolute ethanol. N Engl J Med. 1996 May 16;334(20):1340. doi: 10.1056/NEJM199605163342017. No abstract available.
- Background: PubMed 9576266Lonser RR, Heiss JD, Oldfield EH. Tumor devascularization by intratumoral ethanol injection during surgery. Technical note. J Neurosurg. 1998 May;88(5):923-4. doi: 10.3171/jns.1998.88.5.0923.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemangioma and Neoplasm Metastasis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001417, which also lists 3 linked publications.
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 Mar 2008.