clinical trials ::: acoustic neuroma
A Multicenter Prospective Analysis of Treatment Outcomes in Patients with Large Acoustic Neuromas Receiving Subtotal Resection with Backup Stereotactic Radiation Therapy
The purpose of this research study is to find out more information about the various treatment options already available to patients with a large acoustic neuroma tumors. An acoustic neuroma is a type of benign (non-cancerous) brain tumor that grows in the middle ear. It is one of the most common types of benign brain tumors, and can cause hearing loss.
The auditory nerve (also called the eighth cranial nerve) connects the inner ear to the brain. This nerve is responsible for sending information about hearing and balance to the brain. An acoustic neuroma interferes with the normal pathway for this information. If an acoustic neuroma is not diagnosed or treated, it can grow through the skull bones that make up the middle ear and press on important structures in the brain.
The main symptoms of an acoustic neuroma — dizziness, hearing loss and ringing in the ears (tinnitus) — are caused by the tumor pressing on the auditory nerve. If the tumor grows large enough, it also may press on other nearby nerves and cause weakness, pain or tingling in the face. Although acoustic neuromas are not cancerous, they can become life threatening if they grow so large that they press on parts of the brain that control vital body functions such as breathing.
One way of treating this type of tumor is using Stereotactic Radiosurgery (SRS). SRS is a way of treating many brain disorders with a precise delivery of a single high dose of radiation in a one-day session. Treatment involves the use of focused radiation beams delivered to a specific area of the brain to treat abnormalities, tumors or other functional disorders.
The current standard of practice in most cases is to attempt complete surgical removal of a large acoustic neuroma. Quite often the tumor is found to be attached to the facial nerve (nerve controlling facial expression) and the brainstem. In such cases the surgeons may decide to perform an incomplete or subtotal removal of the tumor. Depending on MRI findings after the surgery, participants would receive radiation therapy. Total removal of such large tumors is associated with high rate of permanent paralysis of the facial nerve and high degrees of hearing loss.
Multiple different US and international sites will take part in the study. A total of 200 subjects will take part in all. At the University of Cincinnati, up to 40 subjects will be enrolled.
After treatment of the of tumor, the study doctor will ask participants to visit the office for standard of care follow up exams at three months, six months, one year, and every year following up to five years. Participants will also undergo MRI screenings prior to each follow up exam.
Eligible participants must be at least 30 years old and have been diagnosed with a large acoustic neuroma tumor (diameter ≥ 2.5 cm) that needs surgical treatment.
Location & contact
Ronald Warnick, MD (Principal investigator)
John Tew, MD
University of Cincinnati Medical Arts Building
For more information, please contact Sireesha Pothukuchi BS CCRP, Regulatory Research Coordinator.
Study Number: Investigator Initiated