Search / Trial NCT00001417

Direct Injection of Alcohol for the Treatment of Spinal Tumors

Launched by NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS) · Nov 3, 1999

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Needle Biopsy Computed Tomography Magnetic Resonance Imaging Spinal Angiography Intratumoral Pressure Vertebral Hemangioma Spinal Metastasis Absolute Ethanol Spinal Tumor Vertebral Tumor

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 ca...

Gender

All

Eligibility criteria

  • 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.

Attachments

readout_NCT00001417_2024-06-14.pdf

4.5 MB

NCT00001417_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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