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

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Diagnostic test, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Contact Information
Primary
RAMONA DAVIS
RDavis18@hfhs.org
3132821753
Backup
REHNUMA NEWAZ
RNewaz1@hfhs.org
3139164123
Time Frame
Start Date: 2021-09-02
Estimated Completion Date: 2026-12-20
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Medtronic
Leads: Henry Ford Health System

This content was sourced from clinicaltrials.gov