Laser Ablation After Stereotactic Radiosurgery

NCT01651078 | Completed Results DMC

• 1 other identifier: LAASR
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Metastatic Brain Tumors; Progression; Radiation Necrosis; Quality of Life

Keywords

Metastatic Brain Tumors; Progression; Radiation Necrosis; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score.

  baseline, 12 and 26 weeks post index procedure

• Overall Survival

  12 and 26 weeks post index procedure

• Percentage of Patients With Laser Ablation Related Adverse Events

  All adverse events reported through 26 weeks post index procedure

Study Arms (1)

Main cohort

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with radiographic evidence of lesion regrowth following prior treatment with radiosurgery (regardless of the process being suspected recurrent or progressive brain metastasis versus radionecrosis).

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Monteris Medical: lead

Study Sites (7)

Yale School of Medicine

New Haven, Connecticut, 06520, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

Washington University in St Louis

St Louis, Missouri, 63110, United States

Location

Carolina Neurosurgery & Spine Associates

Charlotte, North Carolina, 28204, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related 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 tumors and radiation necrosis. J Neurosurg. 2019 Mar 1;130(3):804-811. doi: 10.3171/2017.11.JNS171273. Epub 2018 May 4.

  PMID: 29726782 RESULT

MeSH Terms

Conditions

Brain Neoplasms; Disease Progression

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations are discussed by the physicians in the full publication of the LAASR study data (open access): http://thejns.org/doi/pdf/10.3171/2017.11.JNS171273

Results Point of Contact

• Title: Nissa Mollema (Clinical Operations Manager)
• Organization: Monteris Medical

nmollema@monteris.com

763-253-4710

Study Officials

• Veronica Chiang, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2012
• First Posted: July 26, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 15, 2024
• Results First Posted: August 9, 2019

Record last verified: 2021-08

Locations

US (7)