Recruiting

Laser Ablation & Radiosurgery

Sponsor:

Henry Ford Health System

Code:

NCT05023772

Conditions

Neoplasm Metastasis

Spinal Cord Diseases

Spinal Cord Compression

Spinal Cord Tumor

Spine Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stereotactic Laser Ablation

Stereotactic Radiosurgery

MRI guided laser ablation

Study Details

Brief summary:

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.

Conditions

Neoplasm Metastasis

Spinal Cord Diseases

Spinal Cord Compression

Spinal Cord Tumor

Spine Metastases

Study ID

NCT05023772

Start date

Sep 2, 2021

Status verified date

Jun, 2026

Completion date

Jun 20, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
  • 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.
  • 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.
  • The vertebral body site to be treated must be located from T2 to L1
  • 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.
  • 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).
  • ECOG performance status <2 or Karnofsky performance status (KPS) >50
  • Life expectancy >3 months.
  • Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.
  • 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.
  • Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.
  • Signed informed consent.

Exclusion Criteria:

  • Requires open spinal procedure or a percutaneous procedure without the use of image guidance.
  • 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.
  • Unable to tolerate general anesthesia and prone position.
  • Unable to undergo MRI scan of the spine.
  • Inability to lie flat on a treatment table for >60 minutes.
  • Pregnant. (Urine testing must be done no more than 10 days prior to surgery.)
  • Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.
  • 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)

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental Treatment of Laser Interstitial Thermal Ablation Therapy and Stereotactic Radiosurgery

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.

Interventions

Stereotactic Laser Ablation

MR Guided laser ablation therapy

Stereotactic Radiosurgery

Precise delivery of radiation to spinal tumor

MRI guided laser ablation

Surgery will take place in intraoperative suite to include operating room and MRI scanner

Primary outcome measure

  • Local Tumor Control Rate [ Time Frame: up to 24 months ]

Central Contacts and Locations

Central contacts

RAMONA DAVIS

3132821753RDavis18@hfhs.org

REHNUMA NEWAZ

3139164123RNewaz1@hfhs.org

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

RAMONA DAVIS

3132821753RDavis18@hfhs.org

REHNUMA NEWAZ

3139164123RNewaz1@hfhs.org

Principal Investigator:

IAN LEE, MD, FAANS

More Information

Sponsor

Henry Ford Health System

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Henry Ford Health System on 2026-06-03.