Phase II Cohort of Spinal Stereotactic Radiotherapy in Patients Using a MR LINAC

Study Purpose

To learn whether giving spinal stereotactic radiosurgery (SRSS) that uses a more advanced imaging scan method called Magnetic Resonance imaging with a Linear Accelerator (MR-LINAC) during treatment will lead to improved responses to treatment and better quality of life. SRSS is radiation therapy given to the area around your spine.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

INCLUSION CRITERIA:

1. Age ≥ 18 years old. 2. Radiographically documented disease of the spine within 4 weeks of registration (candidates with or without epidural disease allowed) 3. Candidate for spine SRS/SBRT as determined by treating Radiation Oncologist or Multidisciplinary Spine Conference review. 4. Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated allowed. 5. Diagnosis of cancer documented. 6. Motor strength ≥ 4 out of 5 in the extremity affected by the level of spinal disease planned for radiation. 7. Karnofsky Performance score (KPS) ≥ 40 or ECOG score ≤ 3.

EXCLUSION CRITERIA:

1. Patients with highly radiosensitive histologies likely to respond to conventional radiation therapy alone (ie lymphoma, multiple myeloma, etc) 2. Patients who are unable to undergo MRI of the spine with contrast. 3. Patients who are pregnant

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05709782
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	M.D. Anderson Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Debra N. Yeboa, MD
Principal Investigator Affiliation	M.D. Anderson Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Disease
Study Website:	View Trial Website

Additional Details

Primary objective: • To determine the 6-month local control (LC) of the target site of treatment. Secondary Objectives: - To determine the 6-month change in epidural tumor volume (by volumetric measurements where applicable) - To determine the 1-year local control of the target site

Arms & Interventions

Arms

Experimental: Group 1 (Therapeutic Cohort)

Participants in Group 1 will receive spine radiosurgery on the MR LINAC machine, along with imaging scans using the same machine.

Experimental: Group 2 (Imaging-only Cohort)

Participants in Group 2 will receive spine radiosurgery using a standard radiation therapy machine and have the opportunity to get imaging on the MR LINAC.

Interventions

Procedure: - Spine Radiosurgery

scan

Device: - Magnetic Resonance imaging

scan

Radiation: - MR-LINAC

scan

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

M D Anderson Cancer Center, Houston, Texas

Status

Recruiting

Address

M D Anderson Cancer Center

Houston, Texas, 77030

Site Contact

Debra Yeboa, MD

[email protected]

713-563-2415

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