RECRUITING

Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases

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Conditions

Neoplasm MetastasisSpinal Cord DiseasesSpinal Cord CompressionSpinal Cord TumorSpine MetastasesLaser AblationSpinal CordMinimally Invasive Surgical ProcedureStereotactic RadiosurgeryPain ControlMetastasisEpidural Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Clinical Trial Evaluating the Efficacy of Combining Laser Interstitial Thermal Ablation With and Without Spine Stereotactic Radiosurgery for Patients With Spine Metastases

Quick Facts

Study Start:2021-09-02
Study Completion:2025-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05023772

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
  2. * Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive histologic subtypes, see Exclusion Criteria), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors.
  3. * Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3 by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not required.
  4. * The vertebral body site to be treated must be located from T2 to L1
  5. * No more than 3 contiguous or dis-contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.
  6. * Motor strength ≥4 out of 5 in extremity or extremities affected by the level of the spinal cord compression (see section 4 for grading method).
  7. * ECOG performance status \<2 or Karnofsky performance status (KPS) \>50
  8. * Life expectancy \>3 months.
  9. * Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.
  10. * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  11. * Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.
  12. * Signed informed consent.
  1. * Requires open spinal procedure or a percutaneous procedure without the use of image guidance.
  2. * Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors), as conventional radiation is likely to be effective in such cases.
  3. * Unable to tolerate general anesthesia and prone position.
  4. * Unable to undergo MRI scan of the spine.
  5. * Inability to lie flat on a treatment table for \>60 minutes.
  6. * Pregnant. (Urine testing must be done no more than 10 days prior to surgery.)
  7. * Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.
  8. * Frank cord compression or cord compression from bone components or configuration and acute neurological deficits (defined as motor strength \<4/5 in extremity or extremities affected by the level of the spinal cord compression)

Contacts and Locations

Study Contact

RAMONA DAVIS
CONTACT
3132821753
RDavis18@hfhs.org
REHNUMA NEWAZ
CONTACT
3139164123
RNewaz1@hfhs.org

Principal Investigator

Ian Lee, MD
PRINCIPAL_INVESTIGATOR
Henry Ford Health Health System

Study Locations (Sites)

Henry Ford Hospital
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

  • Ian Lee, MD, PRINCIPAL_INVESTIGATOR, Henry Ford Health Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-02
Study Completion Date2025-09

Study Record Updates

Study Start Date2021-09-02
Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

  • Laser Ablation
  • Spinal Cord
  • Minimally Invasive Surgical Procedure
  • Stereotactic Radiosurgery
  • Pain Control
  • Metastasis
  • Epidural Tumor

Additional Relevant MeSH Terms

  • Neoplasm Metastasis
  • Spinal Cord Diseases
  • Spinal Cord Compression
  • Spinal Cord Tumor
  • Spine Metastases