An interventional study of Stereotactic Laser Ablation and Stereotactic Radiosurgery in Neoplasm Metastasis, Spinal Cord Diseases and Spinal Cord Compression, sponsored by Henry Ford Health System. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment
The purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve quality of life. We will also assess how effective these combined modes of treatment are in patients with spinal metastasis with an epidural component.
Primary Objectives:
Secondary Objectives:
To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months
4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 3,268 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will undergo laser interstitial thermal ablation and CT guided stereotactic radiosurgery via intensity-modulated radiation therapy on different dates within a one to fourteen day window. The order of treatment is at the treating physicians discretion.
Procedure: Stereotactic Laser Ablation · Radiation: Stereotactic Radiosurgery · Diagnostic Test: MRI guided laser ablation
MR Guided laser ablation therapy
Also known as: Thermal laser ablation therapy, Visualase laser ablation therapy
Precise delivery of radiation to spinal tumor
Also known as: CT guided stereotactic radiosurgery, Stereotactic external beam radiation therapy
Surgery will take place in intraoperative suite to include operating room and MRI scanner
Also known as: Intraoperative MRI
Local Tumor Control Rate
Kaplan-Meier estimates will be used.
Time frame: up to 24 months
Local Tumor Control
Time to local failure will be monitored continuously using Bayesian method.
Time frame: 1, 3, 6, 9, 12, 18, and 24 months
Postoperative response to treatment assessed by MRI
Routine MRI of the spine with and without contrast will be obtained at each follow-up visit. These post-treatment scans will be analyzed and compared to baseline scans for assessment of treatment response and local control. Bilsky grading system will be used.
Time frame: 1, 3, 6, 9, 12, 18, and 24 months
Adverse Events
To describe adverse side effects after treatment and descriptively correlate those effects with radiographic findings, pain control, and quality of life.
Time frame: up to 24 months
Overall Survival
Kaplan-Meier estimates will be used.
Time frame: 6, 12, 18, and 24 months
Changes in symptoms assessed by physical examination
The Physical Exam includes a general exam:(HEENT) Head, Eye, Ear, Nose and Throat evaluation, chest, heart, abdomen and extremities exam. Changes will be compared to baseline measurements. Negative changes will be evaluated by the neurosurgeon and radiation oncologist to determine if the change is related to a local failure or progression of systemic disease. Kaplan-Meier estimates will be used.
Time frame: 1, 3, 6, 9, 12, 18, 24 months and annually thereafter
Changes in symptoms assessed by neurological examination
The neurological examination includes: mental status (tested through history taking), cranial nerves (observation of eyes, face, voice, and coordination during history taking and as patient moves about the exam room), motor system (visual inspection, tone, muscle strength and endurance, assigned score of 0-5 for each muscle, a score of 0 would mean no muscular contraction, and a score of 5 would mean movement against full resistance, normal strength), reflexes, sensory system (vibration in toes; pinprick in feet); coordination (truncal stability, fine finger movement, toe tapping, finger-nose-finger, heel-knee-shin), and station and gait (gait including arising from chair without hands, walking on toes, heels, and heel to toe). Kaplan-Meier estimates will be used.
Time frame: 1, 3, 6, 9, 12, 18, and 24 months
Measuring Quality of life (QOL) assessed by Spine Tumor Survey (MDASI-SP)
We are measuring quality of life with the Spine Tumor Survey that will be assessed during each follow up Clinic visit. The patient survey will be assessed to measure postoperative response to treatment.
Time frame: baseline and 1, 3, 6, 9, 12, 18, and 24 months
Measuring Quality of life (QOL) assessed by Health Survey (SF-36)
We are measuring quality of life with the Health Survey that will be assessed during each follow up Clinic visit. The participants are asked questions that measure eight health domains to assess physical and mental health. Physical health-related domains include: General health, Physical Functioning, Role Physical, and Body Pain. Mental health-related scales include Vitality, Social Functioning, Role Emotional, and Mental Health. A 3 and 5 point Likert scale is used in the survey. Two summary scores of the physical and mental health using weighted means of the eight domains. Descriptive statistics will be used to summarize pain relief and quality of life at each follow up visit, which will be the changes in scores from baseline to each assessment visit. Time to maximum pain relief will be the time from the day of thermal ablation until the lowest pain score for average pain after radiotherapy.
Time frame: baseline and 1, 3, 6, 9, 12, 18, and 24 months
Measuring Quality of life (QOL) assessed by Brief Pain Inventory Survey (BPI)
We are measuring quality of life with the Brief Pain Inventory Survey that will be assessed during each follow up Clinic visit. The patient survey will be assessed to measure postoperative response to treatment. Participants are asked to assess the severity of pain and the impact of pain on daily functions. Severity of pain, including the pain location, worst pain in the last 24 hours, least pain in the last 24 hours, pain on average and pain right now. Range 0-10: a score of 0 would mean no pain and a score of 10 means the pain is as bad as you can imagine. Pain medications, amount of pain relief in the past 24 hours, and impact of pain on daily function, including general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life, and range 0-10.
Time frame: baseline and 1, 3, 6, 9, 12, 18, and 24 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Sep 2021 (actual). Primary completion is estimated for Sep 2027, 71 months after the start.
Of 291 non-industry interventional studies with no phase under Neoplasm Metastasis, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 93. This study's planned 71 months is above that.
Counting every sponsor, half of 316 studies reached it within 54 months; a quarter within 28 and three quarters within 91.
How these figures are worked out, and which studies are left out of them.
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