Clinical trial NCT01651078: Laser Ablation After Stereotactic Radiosurgery
Official title: Laser Ablation After Stereotactic Radiosurgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Brain Tumors
Progression
Radiation Necrosis
Quality of Life
Keywords: Metastatic Brain Tumors
Progression
Radiation Necrosis
Quality of Life
Lead sponsor: Monteris Medical
Sponsor class: INDUSTRY
First posted: 2012-07-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Patients With Progression-Free Survival (PFS)
timeFrame: Images were collected at 12 and 26 weeks post index procedure.
Secondary outcomes:
measure: Quality of Life (Change in The Functional Assessment of Cancer Therapy-Brain (FACT-Br) Score.
timeFrame: baseline, 12 and 26 weeks post index procedure
measure: Overall Survival
timeFrame: 12 and 26 weeks post index procedure
measure: Percentage of Patients With Laser Ablation Related Adverse Events
timeFrame: All adverse events reported through 26 weeks post index procedure
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Saint Louis
country: United States
facility: Washington University in St Louis
state: Missouri
city: Charlotte
country: United States
facility: Carolina Neurosurgery & Spine Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Yale University
name: Veronica Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.