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Virus Therapy

Laser Ablation + Radiosurgery for Spinal Cancer

N/A
Recruiting
Led By Ian Lee, MD
Research Sponsored by Henry Ford Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status <2 or Karnofsky performance status (KPS) >50
Motor strength ≥4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6, 9, 12, 18, and 24 months
Awards & highlights

Study Summary

This trial is testing a new way to treat tumors near the spinal cord by combining two existing treatment methods. The goal is to improve tumor control and quality of life for patients with spinal metastasis.

Who is the study for?
This trial is for adults over 18 with inoperable spinal tumors from T2 to L1, not due to highly radiosensitive cancers like lymphoma. They must have a life expectancy over 3 months, agree to contraception if applicable, and be able to tolerate anesthesia and MRI scans. Participants should not be pregnant or have had recent radiation therapy on the same spine area.Check my eligibility
What is being tested?
The study tests combining laser interstitial thermal ablation (LITA) with stereotactic spine radiosurgery (SSRS) for treating spinal metastases near the cord. It aims to see if this combo improves tumor control, pain relief, function preservation, and overall quality of life.See study design
What are the potential side effects?
Potential side effects may include discomfort or complications from general anesthesia, heat damage to surrounding tissues during ablation, skin irritation or burns from radiosurgery, as well as typical risks associated with MRI-guided procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all self-care but may not be able to do heavy physical work.
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I can move my arms or legs where my spine is compressed fairly well.
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The part of my spine needing treatment is between my upper back and mid-back.
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I am older than 18 years.
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My MRI shows I have a significant spinal cord compression.
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My spine cancer affects no more than 3 separate or connected areas.
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My cancer is a solid tumor and not highly sensitive to radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6, 9, 12, 18, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6, 9, 12, 18, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Local Tumor Control Rate
Secondary outcome measures
Adverse Events
Neurologic Examination
Changes in symptoms assessed by physical examination
+3 more
Other outcome measures
Measuring Quality of life (QOL) assessed by Brief Pain Inventory Survey (BPI)
Measuring Quality of life (QOL) assessed by Health Survey (SF-36)
Measuring Quality of life (QOL) assessed by Spine Tumor Survey (MDASI-SP)

Side effects data

From 2019 Phase 2 trial • 32 Patients • NCT01573702
32%
Fatigue
28%
Lymphocyte count decreased
24%
Cough
20%
Back pain
20%
Rash acneiform
16%
Anorexia
16%
Dry skin
16%
Hyperglycemia
16%
Rash maculo-papular
12%
Aspartate aminotransferase increased
12%
Non-cardiac chest pain
12%
Diarrhea
12%
Dyspepsia
12%
Headache
12%
Nausea
12%
Pain
12%
Pain in extremity
8%
Myalgia
8%
Watering eyes
8%
Wheezing
8%
Urinary tract pain
8%
Weight loss
8%
Arthralgia
8%
Edema limbs
8%
Abdominal pain
8%
Paronychia
8%
Pruritus
8%
Blurred vision
8%
Skin and subcutaneous tissue disorders - Other, specify
4%
White blood cell decreased
4%
Lethargy
4%
Infusion site extravasation
4%
Skin infection
4%
Sore throat
4%
Upper respiratory infection
4%
Urinary tract infection
4%
Urinary urgency
4%
Vomiting
4%
Insomnia
4%
Ear pain
4%
Oral hemorrhage
4%
Conjunctivitis
4%
Alkaline phosphatase increased
4%
Blood bilirubin increased
4%
Bone pain
4%
Bruising
4%
Depression
4%
Dry eye
4%
Dysgeusia
4%
Dysphagia
4%
Edema face
4%
Epistaxis
4%
Flashing lights
4%
Flu like symptoms
4%
Gastroesophageal reflux disease
4%
Hot flashes
4%
Hyperkalemia
4%
Hypernatremia
4%
Nail loss
4%
Nail ridging
4%
Neck pain
4%
Neutrophil count decreased
4%
Papulopustular rash
4%
Platelet count decreased
4%
Pneumonitis
4%
Fracture
4%
Fall
4%
Skin hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Radiosurgery Followed by Erlotinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic RadiosurgeryExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiosurgery
2016
Completed Phase 2
~490

Find a Location

Who is running the clinical trial?

Henry Ford Health SystemLead Sponsor
302 Previous Clinical Trials
2,103,172 Total Patients Enrolled
MedtronicIndustry Sponsor
609 Previous Clinical Trials
828,655 Total Patients Enrolled
Ian Lee, MDPrincipal InvestigatorHenry Ford Health Health System

Media Library

MRI guided laser ablation (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05023772 — N/A
Spinal Metastases Research Study Groups: Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery
Spinal Metastases Clinical Trial 2023: MRI guided laser ablation Highlights & Side Effects. Trial Name: NCT05023772 — N/A
MRI guided laser ablation (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05023772 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participants in this investigation?

"Affirmative. According to clinicaltrials.gov, this research is still actively gathering participants for the experiment. The project was first announced on September 2nd 2021 and most recently updated July 26th 2022 with the intention of recruiting 60 test subjects from a single site."

Answered by AI

What is the estimated sample size for this medical trial's participants?

"Affirmative. The information hosted on clinicaltrials.gov implies that this experiment is actively recruiting participants, having been initially published on September 2nd 2021 and last amended on July 26th 2022. 60 patients are sought to take part at 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Michigan
How old are they?
18 - 65
What site did they apply to?
Henry Ford Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
Ian Lee, MD 2021. "Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05023772.
All > Bone Metastases > Metastatic Breast Cancer
~5 spots leftby Sep 2024
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