Laser Ablation After Stereotactic Radiosurgery

Quality of Life Clinical Trial

— LAASR  

Official title:

Laser Ablation After Stereotactic Radiosurgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651078
• Other study ID #: LAASR
• Status: Completed
• Start date: July 2012
• Est. completion date: August 2016

Study information

• Verified date: August 2021
• Source: Monteris Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The need for new technologies and devices in the field of neurosurgery is well established. In April 2013, FDA cleared NeuroBlate™ System, minimally invasive robotic laser thermotherapy tool. It employs a pulsed surgical laser to deliver targeted energy to abnormal brain tissue caused by tumors and lesions. This post-marketing, multi-center study will include patients with metastatic tumors who failed stereotactic radiosurgery and are already scheduled for NeuroBlate procedure. The study will collect clinical outcome, Quality of Life (QoL) and, where feasible, healthcare utilization data for publication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Patient has signed and received a copy of the Informed Consent Form

2. 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.

3. Karnofsky Performance Status (KPS) = 60.

Key Exclusion Criteria:

1. Females who are pregnant, breast feeding, or plan to become pregnant in the 6 months following index procedure.

2. Leptomeningeal metastases.

3. Uncontrolled infectious process.

4. Uncontrolled hypertension (systolic >180 mm Hg), angina pectoris, or cardiac dysrhythmia, or recent (within 6 weeks) history of intracranial hemorrhage.

5. Serious infection, immunosuppression or concurrent medical condition (chronic or acute in nature) that may prevent safe participation or ability to meet follow-up requirements.

6. 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.

7. 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).

Related Conditions & MeSH terms

• Brain Neoplasms
• Disease Progression
• Metastatic Brain Tumors
• Necrosis
• Progression
• Quality of Life
• Radiation Necrosis

Locations

Country	Name	City	State
United States	Carolina Neurosurgery & Spine Associates	Charlotte	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Yale School of Medicine	New Haven	Connecticut
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Washington University in St Louis	Saint Louis	Missouri
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Monteris Medical

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ahluwalia M, Barnett GH, Deng D, Tatter SB, Laxton AW, Mohammadi AM, Leuthardt E, Chamoun R, Judy K, Asher A, Essig M, Dietrich J, Chiang VL. Laser ablation after stereotactic radiosurgery: a multicenter prospective study in patients with metastatic brain — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients With Progression-Free Survival (PFS)	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.	Images were collected at 12 and 26 weeks post index procedure.
Secondary	Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score.	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.	baseline, 12 and 26 weeks post index procedure
Secondary	Overall Survival	To describe/estimate the overall survival after the NeuroBlate Procedure.	12 and 26 weeks post index procedure
Secondary	Percentage of Patients With Laser Ablation Related Adverse Events	To continue to monitor factors impacting the safe and efficacious use of NeuroBlate	All adverse events reported through 26 weeks post index procedure