Laser Ablation After Stereotactic Radiosurgery (LAASR)
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|ClinicalTrials.gov Identifier: NCT01651078|
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : August 9, 2019
Last Update Posted : August 24, 2021
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|Condition or disease|
|Metastatic Brain Tumors Progression Radiation Necrosis Quality of Life|
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|Official Title:||Laser Ablation After Stereotactic Radiosurgery|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Patients with radiographic evidence of lesion regrowth following prior treatment with stereotactic radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radiation necrosis) and who already scheduled for NeuroBlate procedure.
- Percentage of Patients With Progression-Free Survival (PFS) [ Time Frame: Images were collected at 12 and 26 weeks post index procedure. ]To describe local (CNS) progression-free survival rate in patients with failed radiosurgery for brain metastases treated with the NeuroBlate System. Sites were requested to submit imaging to a centralized core laboratory for analysis. A total of 27 patients had images submitted--27/42 (64%) of patients submitted follow-up images at 12-weeks and 16/42 (38%) patients submitted follow-up imaging at 26 weeks. Due to the low submission of follow-up images at 26-weeks, 12-weeks and last follow-up are reported.
- Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score. [ Time Frame: baseline, 12 and 26 weeks post index procedure ]FACT-Br questionnaire sub-scores (Physical well-being, social/family well-being, emotional well-being, functional well-being, brain cancer subscale) are summed together, leading to a FACT-Br total score on a scale from 0-200; larger scores indicate better overall quality of life. This outcome measured the FACT-Br score change from Baseline at both 12 and 26 weeks post NeuroBlate procedure (values at 12 and 26 weeks, respectively, minus value at baseline). Version 4 of the Fact-BR scoring guidelines were used.
- Overall Survival [ Time Frame: 12 and 26 weeks post index procedure ]To describe/estimate the overall survival after the NeuroBlate Procedure.
- Percentage of Patients With Laser Ablation Related Adverse Events [ Time Frame: All adverse events reported through 26 weeks post index procedure ]To continue to monitor factors impacting the safe and efficacious use of NeuroBlate
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
Key Inclusion Criteria:
- Patient has signed and received a copy of the Informed Consent Form
- Patient may have up to 3 target supratentorial metastatic lesions previously treated with stereotactic radiosurgery, with radiological evidence of progression, pseudoprogression or radionecrosis. Subject may have additional non target lesions present as long as they are not expected (in Investigator's judgment) to contribute to symptomatology during the course of the study or confound interpretation of radiological and clinical measures.
- Karnofsky Performance Status (KPS) ≥ 60.
Key Exclusion Criteria:
- Females who are pregnant, breast feeding, or plan to become pregnant in the 6 months following index procedure.
- Leptomeningeal metastases.
- Uncontrolled infectious process.
- Uncontrolled hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia, or recent (within 6 weeks) history of intracranial hemorrhage.
- Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements.
- Abnormal absolute neutrophil count (ANC<1000/mm), platelets (<100,000/mm) or the administration of antiplatelet agents (aspirin, plavix etc) or anticoagulation within 7 days prior to treatment.
- Inadequate bone marrow, liver and renal function (e.g., total bilirubin > 1.5 x ULN; AST, ALT > 2.5 x ULN; alkaline phosphatase > 2.5 x ULN; serum creatinine > 1.5 x ULN).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651078
|United States, Connecticut|
|Yale School of Medicine|
|New Haven, Connecticut, United States, 06520|
|United States, Kansas|
|Kansas University Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, Missouri|
|Washington University in St Louis|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Carolina Neurosurgery & Spine Associates|
|Charlotte, North Carolina, United States, 28204|
|Wake Forest School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Veronica Chiang, MD||Yale School of Medicine|
|Responsible Party:||Monteris Medical|
|Other Study ID Numbers:||
|First Posted:||July 26, 2012 Key Record Dates|
|Results First Posted:||August 9, 2019|
|Last Update Posted:||August 24, 2021|
|Last Verified:||August 2021|
Metastatic Brain Tumors
Quality of Life
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases