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New treatment option for Neoplasm Metastasis
Official title Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
ClinicalTrials.gov ID: NCT05023772
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- ), including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck...
- 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...
- 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 \ 50
See the full eligibility 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
- ), 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 \ 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.