Symptoms and General Pathology

All Conditions

Pain

Analgesics

All Drugs and Chemicals

Antitussive Agents

Central Nervous System Depressants

Respiratory System Agents

Anti-Obesity Agents

Vasoconstrictor Agents

Methadone

Analgesics, Opioid

Narcotics

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Patients will be administered methadone 0.2 mg/kg (max 20 mg).

Jess Brallier, MD

Patrick McCormick, MD

The researchers are doing this study to find out whether giving methadone during spinal surgery helps manage pain in the first 72 hours after surgery better than other standard pain medications. Participants' pain will be measured by how much pain is reported after surgery, and how much additional pain medication is needed to lower pain levels. The researchers will look at whether giving methadone during surgery reduces the need for other pain medications after surgery. In addition, the team will compare the effects of the two standard treatments- one with methadone and one without methadone to to evaluate which one works best.

Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery

Modulation of Post-operative Opioid Consumption and Pain by Intraoperative Methadone for Cancer Related Spinal Surgery - An Investigator Initiated Trial (IIT), Cluster Randomization Trial

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

To see if giving methadone during surgery reduces the need for other pain medications after surgery

Memorial Sloan Kettering Cancer Center

Neoplasms

Nervous System Diseases

Musculoskeletal Diseases

Neoplasm Metastasis

Spinal Cord Neoplasms

Spinal Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Spinal Cord Diseases

Central Nervous System Diseases

Bone Neoplasms

Bone Diseases

Spinal Diseases

MRI images of the spine taken of anesthetized participant in the operative prone position. These images are exported into a computer navigation program, and used to help the doctor perform surgery.

Pain and symptom questionnaires completed at baseline and at follow up.

MRI images of the spine taken of anesthetized participant in the operative prone position.

Magnetic Resonance Imaging (MRI)

Pain and symptom questionnaires completed at baseline and at follow up.

Questionnaires

Claudio E. Tatsui, MD

The goal of this clinical research study is to learn about the safety and accuracy of using MRI as a guidance system during laser ablation surgery of tumors that have spread to the spine.

Study Visits:

If you agree to take part in this study, before your surgery:

* You will have a physical exam.
* You will have a neurological exam (tests to check the functioning of your nerves, including tests of your balance and reflexes).
* You will complete questionnaires about pain and other symptoms that should take about 10-15 minutes.
* You will sign a separate consent for your spinal surgery that explains the risks.

During the Surgery:

You will be positioned lying face down on your stomach during surgery. While you are under anesthesia, an MRI will be used to take images of your spine. This is an intraoperative MRI, meaning that it is performed in a special magnet located inside a specifically designed operating room. These images will be loaded into a computer navigation program and will be used to help the doctor perform surgery.

Markers will also be attached to the skin of your back. These markers are used together with the navigation program and MRI images to record the location of where on your spine the doctor should cut. This recording will be compared to the MRI images.

Your doctor will check the accuracy of this recording in 2 ways:

* Placing the tip of the navigation probe on your skin and comparing it with the computer calculation in the computer navigation program. This is a standard navigation probe commonly used in spinal surgeries.
* Inserting the navigation probe through a small cut on your skin along the surgical area and taking an x-ray image of its location.

If there is a difference in the result of these 2 measurements, your doctor will use the result of the first step to check the accuracy of the MRI image.

If there is more than 2 millimeter difference between the visual inspection position and the computer model position, your doctor may decide to do one of the following steps:

* Restart the recording process by getting a new MRI image
* Use only the x-ray images to complete the procedure
* Stop the surgery

On the Day After Surgery:

* You will have a physical exam.
* You will have a neurological exam.
* You will complete the same questionnaires as before.

Follow-Up Visits:

The research staff will call you 3 weeks after surgery to ask about your recovery and you will be asked to answer the same questionnaires as before.

You will return for a follow-up visit after surgery:

* You will have a physical exam.
* You will have a neurological exam.
* You will complete the same questionnaires as before.

Length of Study Participation:

Your participation in the study will be over after your follow-up visit.

You will be taken off study if during surgery the doctor thinks the navigation is not accurate, you are injured related to an inaccurate image guidance, or your surgery is stopped.

This is an investigational study. The MRIs and x-rays on this study are performed using FDA-approved and commercially available methods. The use of MRI as image guidance for spinal surgery is investigational.

Up to 10 participants will be enrolled in this study. All will take part at MD Anderson.

Safety Evaluation of Intra-Operative MRI-Based Guidance for Laser Ablation of Epidural Metastasis

A Pilot Study to Evaluate Safety of Intraoperative MRI-Based Image Guidance for Laser Ablation of Epidural Metastasis

Safety of Intraoperative MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis

Navigation considered inaccurate if there is a discrepancy of more than 2mm between the real position of the probe confirmed by direct visual inspection, and the computer model displayed on the navigation screen.

M.D. Anderson Cancer Center

single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.

hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.

single-fraction SRS

high-dose hypofractionated SRS

Quality of Life Measures

Ilya Laufer

The purpose of this study is to find out whether giving one higher dose of radiation is as good at treating the tumor in the patient's spine after surgery as giving three lower doses of radiation.

Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases

Phase III Multicenter Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases

will be radiographically determined according to routine standard of care post-surgical and post-treatment imaging (MRI or CT) of the spine. Local tumor control will be defined as the lack of local tumor progression at the irradiated site on follow-up imaging.

Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

will be determined through patient-reported responses of the BPI. Pain severity at its worst (question #5) and the average of the pain interference (average of question #9)

Johns Hopkins University

Massachusetts General Hospital

Stanford University

hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery.

high-dose hypofractionated SRS

Quality of Life Measures

High-dose Hypofractionated SRS (27 Gy in 3 Fractions)

single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery.

single-fraction SRS

Quality of Life Measures

Single-fraction SRS (24 Gy)

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Ilya Laufer, MD

Local Tumor Control Using MRI or CT

Treatment-related Toxicity Using CTCAE v4.0

Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI

Overall Study

Diseases and Abnormalities at or Before Birth

Heart and Blood Diseases

Rare Diseases

Congenital Abnormalities

Fistula

Hydrocephalus

Vascular Malformations

Meningioma

Arnold-Chiari Malformation

Brain Neoplasms

Pathological Conditions, Anatomical

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Brain Diseases

Cardiovascular Abnormalities

Spinal Dysraphism

Neural Tube Defects

Nervous System Malformations

Tethered Cord Syndrome

Chiari Malformation Type 2

Patients receiving Neuro-Patch® for duraplasty

Izabela Firkowska Boden, Dr.

Joachim Oertel, Prof. Dr.

Fritz Teping, Dr. med.

Tschan, Dr. med.

The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer

MiDura-Study (Neuro-Patch in Duraplasty)

Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)

Incidence of complications, with (potential) causal relationship to Neuro-Patch

Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)

Incidence of complications, without causal relationship to Neuro-Patch

Aesculap AG

Hemorrhage

Blood Loss, Surgical

Neoplasms, Second Primary

32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.

32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery.

Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.

Arteriography and preoperative embolization

Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.

Arteriography

Lars Lönn, MD, Ph.d.

The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at describing the vascularity in a series of spinal metastasis, and to correlate this with perioperative blood loss.

Preoperative Embolization in Surgical Treatment of Spinal Metastases.

Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.

Defined as the amount of time (measured in minutes) from skin incision to skin closure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery	NCT05417100	Spinal Surgery	Methadone	18 Years - 75 Years	Memorial Sloan Kettering Cancer Center
Safety Evaluation of Intra-Operative MRI-Based Guidance for Laser Ablation of Epidural Metastasis	NCT02613390	Spinal Tumor	Magnetic Resona... Questionnaires	18 Years -	M.D. Anderson Cancer Center
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases	NCT02320825	Spinal Metastas...	single-fraction... high-dose hypof... Quality of Life...	18 Years -	Memorial Sloan Kettering Cancer Center
Safety Evaluation of Intra-Operative MRI-Based Guidance for Laser Ablation of Epidural Metastasis	NCT02613390	Spinal Tumor	Magnetic Resona... Questionnaires	18 Years -	M.D. Anderson Cancer Center
MiDura-Study (Neuro-Patch in Duraplasty)	NCT04189172	Meningioma Tumor, Brain Chiari Malforma... Vascular Malfor... Hydrocephalus Tethered Cord Dural Fistula Craniotomy Spinal Surgery Duraplasty		18 Years -	Aesculap AG
Randomized Study Comparing Local Tumor Control After Post-Operative Single-Fraction or Hypofractionated Stereotactic Radiosurgery in the Treatment of Spinal Metastases	NCT02320825	Spinal Metastas...	single-fraction... high-dose hypof... Quality of Life...	18 Years -	Memorial Sloan Kettering Cancer Center
Preoperative Embolization in Surgical Treatment of Spinal Metastases.	NCT01365715	Spinal Metastas...	Arteriography a... Arteriography	18 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for spinal surgery