Breaking News
October 23, 2018 - Map of human liver cells reveals molecular make-up of individual cells
October 23, 2018 - Drugs approved for breast cancer treatment are effective and well tolerated in men
October 23, 2018 - EKF introduces new hand-held lactate analyzer for rapid sports performance monitoring
October 23, 2018 - Researchers identify common genetic connection in lung conditions
October 23, 2018 - Forbius initiates Phase 2a trial evaluating efficacy, safety of AVID100 in patients with squamous NSCLC
October 23, 2018 - Immunotherapy achieves major pathological response in early-stage mismatch repair deficient colon cancer
October 23, 2018 - New discovery may lead to better treatment options for pancreatic cancer patients
October 23, 2018 - FDA Approves Dupixent (dupilumab) for Moderate-to-Severe Asthma
October 23, 2018 - Researchers identify immune culprits linked to inflammation and bone loss in gum disease
October 23, 2018 - Despite lower risk factors, black men have higher rates of recidivism
October 23, 2018 - Study finds why pregnant women in mainland China, Hong Kong and Taiwan prefer cesarean delivery
October 23, 2018 - AbbVie’s U-ACHIEVE Phase 2b/3 dose-ranging study improves outcomes in patients with ulcerative colitis
October 23, 2018 - NCI grant awarded to Abramson Cancer Center to study CAR T cells In solid tumors
October 23, 2018 - Scientists use electron microscope to study chemical transformation in catalytic cross-coupling reaction
October 23, 2018 - Research offers new hope to men who received childhood cancer treatment
October 23, 2018 - Adverse Childhood Experiences Tied to Burnout in BSN Students
October 23, 2018 - High levels of oral disease among elite athletes affecting performance
October 23, 2018 - Study examines effect of immediate vs delayed pushing during labor on delivery outcomes
October 23, 2018 - LU-RRTC to spearhead capacity-building efforts for racial and ethnic populations
October 23, 2018 - Maintenance therapy with olaparib improves progression-free survival in advanced ovarian cancer patients
October 23, 2018 - Organic food may protect against cancers finds study
October 23, 2018 - Interweaving anxiety disorder associated with stuttering remains unrecognized
October 23, 2018 - Cannabis oil shown to significantly improve Crohn’s disease symptoms
October 23, 2018 - Knowledge of sex differences in lower urinary tract may help stimulate breakthroughs in diagnosis, management
October 23, 2018 - Common antibodies associated with myocardial infarction
October 23, 2018 - Study reveals new treatment option for women with advanced breast cancer resistant to hormone therapy
October 23, 2018 - Brain’s ‘Self-Control’ Center May Be Key to Weight-Loss Success
October 23, 2018 - Prosthetic valve mismatches common in transcatheter valve replacement, ups risk of death
October 23, 2018 - Can virtual reality help people become more compassionate?
October 23, 2018 - Screen time eclipsed outdoor time for most students, shows study
October 23, 2018 - SLU researcher seeks to find solutions for ‘chemo brain’ symptoms and side effects of opioids
October 23, 2018 - Plastics now commonly found in human stools
October 23, 2018 - Zoledronic acid increases disease-free survival in premenopausal women with HR+ early breast cancer
October 23, 2018 - Cancer survivors at risk for heart failure during, after pregnancy
October 23, 2018 - Stanford project brings health education videos to mothers in South Africa
October 23, 2018 - HIV-infected Hispanics at higher risk of developing HPV-related cancers, finds study
October 23, 2018 - Politicians hop aboard ‘Medicare-for-all’ train, destination unknown
October 23, 2018 - Study suggests rising childhood obesity rates as cause for serious hip disease in adolescents
October 23, 2018 - Study highlights existence of barriers to early clinical trial access for adolescents and young adults
October 23, 2018 - Protein sequencing technique could revolutionize biomedical research
October 23, 2018 - Canon Medical to showcase world’s first Ultra-High Resolution CT system at ASTRO 2018
October 23, 2018 - Spectrum Pharmaceuticals Announces Release of Updated Poziotinib Data From MD Anderson Phase 2 Study in Non-Small Cell Lung Cancer Patients
October 23, 2018 - Cancer stem cells use ‘normal’ genes in abnormal ways
October 23, 2018 - Bad Blood: A conversation with investigative reporter John Carreyrou | News Center
October 23, 2018 - As U.S. fertility rates collapse, finger-pointing and blame follow
October 23, 2018 - Researchers develop promising targeted strategy to treat chemo-resistant blood cancer
October 23, 2018 - Pilot clinical trial shows effectiveness of bioelectronic medicine device for lupus
October 23, 2018 - Genentech’s combination therapy improves outcome in patients with non-squamous non-small cell lung cancer
October 23, 2018 - 11th World Stroke Congress examines high stroke impact in low- and middle-income countries
October 22, 2018 - Breast cancer survival could be extended with two new drug combinations
October 22, 2018 - Researchers discover how acne-causing bacteria resist treatment
October 22, 2018 - Cancer trial shows treating the prostate with radiotherapy improves survival
October 22, 2018 - New hope for a drug to treat lymphedema symptoms
October 22, 2018 - Immune-Based Treatment Helps Fight Aggressive Breast Cancer, Study Finds
October 22, 2018 - Takeda announces positive Phase 3 ALTA-1L data in first-line therapy for advanced ALK+ NSCLC
October 22, 2018 - Paternal exercise has significant impact on child’s lifelong metabolic health
October 22, 2018 - Targeting specific genomic mutation in breast cancer improves survival
October 22, 2018 - Loss of tumor protein p53 helps cancer cells grow in hostile environment
October 22, 2018 - IDT to demonstrate CRISPR expertise at European-focused events
October 22, 2018 - Breathing through the nose improves memory consolidation
October 22, 2018 - Recreational Marijuana Now Legal in Canada
October 22, 2018 - Scientists reveal drumming helps schoolchildren diagnosed with autism
October 22, 2018 - A stage IV cancer patient discusses what it means to live well with serious illness
October 22, 2018 - In Kids with Autism, Short Questionnaire May Detect GI Disorders
October 22, 2018 - Innovative strategy opens up new avenue of treatment for anthrax infections
October 22, 2018 - Merck presents MK-1454 Phase 1 data for treatment of advanced solid tumors or lymphomas
October 22, 2018 - Aspirin may be effective in preventing blood clots after knee replacement
October 22, 2018 - Drug cocktail that increases lifespan discovered
October 22, 2018 - Gilead Sciences presents Phase 3 results of filgotinib in biologic-experienced rheumatoid arthritis at 2018 ACR/ARHP Annual Meeting
October 22, 2018 - Study shows potential positive impact of group prenatal care on birth outcomes
October 22, 2018 - Immunotherapy with pembrolizumab extends survival in metastatic or recurrent head and neck cancer
October 22, 2018 - Health Tip: Keep Ticks Away
October 22, 2018 - Obsessive-compulsive disorder – Genetics Home Reference
October 22, 2018 - Researchers find disrupted functional connectivity in cerebellum of adults with HF-ASD
October 22, 2018 - Deciphera presents Phase 1 clinical results of DCC-2618 in patients with gastrointestinal stromal tumors
October 22, 2018 - Combination of Opdivo and Yervoy shows four-year survival benefits in patients with advanced melanoma
October 22, 2018 - Overcoming bottlenecks in early drug discovery with the power of sound
October 22, 2018 - Scientists discover genes that contribute to ADHD development
October 22, 2018 - Incyte announces Phase 2 FIGHT-202 trial data in patients with cholangiocarcinoma
October 22, 2018 - FDA approves update to Rituxan label to include information on treatment of rare forms of vasculitis
FDA Alert: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers

FDA Alert: Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers

image_pdfDownload PDFimage_print

April 25, 2018

[Posted 04/25/2018]

AUDIENCE: Neurology, Risk Manager

ISSUE: FDA is providing preliminary information concerning magnetic resonance (MR) thermometry reliability with magnetic resonance-guided laser interstitial thermal therapy (MRgLITT) devices.

FDA is currently evaluating data which suggests that potentially inaccurate MR thermometry information can be displayed during treatment. For example, MR parameters such as voxel size (measurement of the image resolution or detail) and MR image acquisition time (e.g., up to 8 seconds) may contribute to inaccurate MR thermometry readings and potential errors in the ablation assessment. In addition, MRgLITT devices may not account for the continued thermal spread of energy to the surrounding tissue (as the target ablation area returns to its baseline temperature), which may result in an underestimation of thermal damage.

The FDA has reviewed Medical Device Reports (MDRs) and literature reports which describe adverse events such as neurological deficits (e.g., focal motor deficits, aphasia, cognitive changes), increased intracerebral edema or pressure, intracranial bleeding, and/or visual changes (e.g., visual field deficits, blurry vision) when these devices were used to treat intra-cranial lesions. Several of these reports note events which required urgent medical and/or surgical intervention, and may have been associated with patient deaths. However, it is unclear at this time, whether an inaccuracy of MR thermometry directly caused or contributed to these events.

BACKGROUND: MRgLITT devices are commonly used in neurosurgical procedures for minimally invasive ablation of brain tumors, epileptic foci, or radiation necrosis. During these procedures, the tip of a laser probe is stereotaxically placed within the tissue to be ablated, and controlled thermal energy is delivered to the target tissue. MR thermometry is used to monitor the changes in temperature at the treatment site using a Magnetic Resonance Imaging (MRI) scanner, and proprietary software information is displayed on a workstation to aid the physician in assessing and controlling thermal damage.

RECOMMENDATION:

The FDA recommends that health care providers

  • Consider and discuss with your patients the benefits and risks of these devices, as well as the availability of any alternative treatment modalities on an individual patient basis. Should an MRgLITT device be the best available treatment option:

    • Physicians should consider heating the target tissue slowly to reduce the potential for inaccurate MR thermometry readings. Additionally, heating the tissue slowly may lessen unanticipated thermal spread. For example:
      • Heating tissue at a rate of 4 degrees Celsius per second, and an MR acquisition time of 8 seconds, may result in uncertainties of up to 32 degrees Celsius during MR thermometry readings
      • Heating tissue at a rate of 1 degrees Celsius per second, and an MR acquisition time of 8 seconds, may result in uncertainties of up to 8 degrees Celsius during MR thermometry readings
    • While heating the target tissue slowly, physicians should also consider using one of the following settings to mitigate the risk of unintended damage to surrounding tissue or nearby critical structures:
      • Set the low temperature targets on nearby critical structures to 43 degrees Celsius or less
      • Follow the outer perimeter or isothermal contour line at the Cumulative Equivalent Minutes of 43 degree Celsius (CEM43)=2 minutes or less so that no critical structures are within the contour line
    • Contact the applicable manufacturer for further information regarding recommended heating parameters
  • Report problems to the FDA
    • Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Please include the following information in the report, if known:
      • Information on the manufacturer, brand of MRgLITT device used
      • Reason for treatment (e.g. tumor ablation, epileptic foci, etc.)
      • Anatomical location of treatment
      • Peak temperature, time needed to reach the peak temperature, and total laser-on time for each ablation
      • Information on the MRI (manufacturer, brand, field strength, transmit coil, receive coil, and MR imaging parameters)
      • Thermal damage dimensions estimated by the device; and actual thermal damage dimensions as measured by the health care provider
      • Patient outcome and whether additional treatment was needed
         

[04/24/2018 – Letter to Health Care Providers – FDA]

Tagged with:

About author

Related Articles