Treatment Trials

16 Clinical Trials for Various Conditions

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RECRUITING
Single- vs. Two-Fraction Spine Stereotactic Radiosurgery for the Treatment of Vertebral Metastases
Description

Spine radiosurgery (SRS) utilizes advanced treatment planning with focused x-rays to deliver one to four high dose treatments to the spine to help relieve pain and/or neurologic symptoms. Spine SRS uses special equipment to position the participant and guide the focused beams toward the area to be treated and away from normal tissue. One of the side effects of spine SRS is the development of vertebral compression fractures, many of which are not painful. The goal of this study is to compare the effects, good and/or bad, of spine SRS given in 1 or 2 treatments. Our main goal is to find out which approach will reduce the chances of developing vertebral compression fractures.

TERMINATED
Phase II Trial of Stereotactic Radiation Therapy (SRT) Versus SRT Plus Vertebral Augmentation Procedure (VAP) for Vertebral Metastasis
Description

The purpose of this study is to determine pain control rate (Percentage of patients in each arm that achieve pain control) at the treated site(s) at 1 month, 2-4 months and 5-6 months post-treatment.

COMPLETED
Effect of Samarium on the Relief of Pain Due to Vertebral Metastases
Description

Cancer cells may spread from the primary site to the vertebrae resulting in their deformity. The standard treatment for this case is removal of the cancer deposits in the vertebra and filling the induced cavity with a cement like substance. The investigators are studying the effects (good or bad) of adding samarium (a radioactive substance) to the cement that is injected into the induced cavity.

TERMINATED
Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine
Description

The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. This study involves patients who have been diagnosed with metastatic cancer to the thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the area of concern. The goal is to prove that this is not only a safe form of treatment, but that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer coming back in the area that the investigators treat which may reduce the risk of developing symptoms like pain in the future.

COMPLETED
Stereotactic Body Radiotherapy for Spine Tumors
Description

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.

TERMINATED
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
Description

The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.

COMPLETED
The STAR Prospective Clinical Series
Description

Prospective clinical series to gather post tumor ablation clinical outcomes from subjects with painful spinal metastases following targeted radiofrequency ablation (t-RFA) treatment with the STAR™ Tumor Ablation System.

TERMINATED
The STAR™ Tumor Ablation Registry
Description

Registry collecting data on use of The STAR™ Tumor Ablation System.

COMPLETED
The Epidemiology, Process and Outcomes of Spine Oncology (EPOSO)
Description

The main purpose of this study is to utilize a comprehensive, prospective clinical database to collect patient, diagnostic and treatment variables along with disease specific and generic health related quality of life (HRQOL) data on consecutively treated patients with metastatic spine tumors. The objectives are to determine the validity and reliability of the Spine Cancer Outcomes Questionnaire (SCOQ) for use in the assessment of spine tumor outcomes, to determine if the Spine Instability Neoplastic Score (SINS) Classification is a valid tool for predicting the stability of spine in metastatic spine disease, and to determine the efficacy of surgery versus radiotherapy for the treatment of impending instability secondary to metastatic disease of the spine.

TERMINATED
Vertebral Augmentation and Radiotherapy of Collapse Spinal Metastatic Cancer
Description

Vertebral augmentation with radiotherapy to increase the functional status and quality of life for patients with vertebral body metastatic cancers.

ACTIVE_NOT_RECRUITING
Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation
Description

The spread of cancer to the spine is referred to as spine metastasis. Spine metastases are a common complication of cancer and are frequently associated with significant back pain. This study is being done to help improve treatment for back pain caused by spinal metastases by comparing the effectiveness of two standard treatments. These two treatments include radiation therapy (RT) alone versus radiation therapy combined with radiofrequency ablation, with or without vertebral augmentation (PVA/RFA). In addition to RT or RT with PVA/RFA, will be continued with current pain medications.

ACTIVE_NOT_RECRUITING
Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases
Description

The purpose of this study is to determine if quantitative magnetic resonance imaging (qMRI) can objectively measure changes in the tumor/vertebral body and adjacent spinal cord following stereotactic body radiation therapy (SBRT) for painful metastatic spine disease.

COMPLETED
Assessment of Vertebral Fracture Risk for First Time Liver Transplant Candidates
Description

The researchers are trying to compare the effectiveness of Vertebral Fracture Assessment (VFA) in addition to the current standard of care spine x-ray in evaluation pre-liver transplant patients.

ACTIVE_NOT_RECRUITING
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Description

This randomized phase II trial studies how well cement augmentation works in preventing vertebral body compression fracture following spine stereotactic radiosurgery in patients with solid tumors that have spread to the spine. Spine stereotactic radiosurgery delivers a high dose of radiation to vertebral metastases and can sometimes lead to a vertebral compression fracture. Using body cement on the largest part of the vertebra (a procedure called vertebral body cement augmentation) may help prevent a fracture after stereotactic spinal radiosurgery. It may also lessen pain and improve quality of life in patients with solid tumors and spinal metastases undergoing this surgery.

COMPLETED
Direct Injection of Alcohol for the Treatment of Spinal Tumors
Description

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.

COMPLETED
FREE Study - Fracture Reduction Evaluation
Description

The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.