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New treatment option for Brain Metastases
Official title Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM)
ClinicalTrials.gov ID: NCT07053033
What this study is testing
- What it's testing
- standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).
- Phase 2: a mid-size study of how well it works
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
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SRS2, children are excluded from this study.
- Karnofsky performance status ≥ 60.
- Radiographic concern for progression of a solid tumor brain metastasis that has received prior stereotactic radiosurgery ≥ 3 months prior to study...
You likely can't join if
- Patients with brain metastases from hematologic malignancies due to significant differences in radiosensitivity and treatment paradigms.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. All female patients between...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
See the full eligibility criteria
- Ability to understand and the willingness to sign a written informed consent document.
- Willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SRS2, children are excluded from this study.
- Karnofsky performance status ≥ 60.
- Radiographic concern for progression of a solid tumor brain metastasis that has received prior stereotactic radiosurgery ≥ 3 months prior to study enrollment.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥5 mm with MRI scan.
- Have active tumor on pathology from surgery/LITT for this lesion.
- Able to safely undergo MRI imaging.
- Acceptable candidate for SRS2 per treating physician and multidisciplinary conference consensus.
- Have no radiographic evidence of leptomeningeal disease on radiology report or neuro-radiologist review.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or how well it works assessment of the investigational regimen are eligible for this trial.
- Patients with brain metastases from hematologic malignancies due to significant differences in radiosensitivity and treatment paradigms.
- Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. All female patients between the onset of menses and 55 years will receive a pregnancy test prior...
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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 Houston, Texas, 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.