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Image-guided ultrasound ablation for precision targeting of prostate cancer

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基本信息

批准号：
10449277
负责人：
Everette C Burdette
金额：
$ 59.65万
依托单位：
ACOUSTIC MEDSYSTEMS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-07 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10449277
关键词：
3-Dimensional 3D ultrasound Ablation Accounting Affect Algorithms Ambulatory Surgical Procedures Anatomy Anterior Biological Models Biopsy Brachytherapy Breast Diseases Cancer Patient Canis familiaris Cause of Death Characteristics Clinical Clinical Research Cold Therapy Complex Computer Models Computers Conformal Radiotherapy Coupled Couples Data Development Device Designs Device or Instrument Development Devices Diagnosis Diagnostic Disease Early Diagnosis Effectiveness Electromagnetics External Beam Radiation Therapy FDA approved FOLH1 gene Feedback Focused Ultrasound Therapy Freezing Gases Gland Goals Gold Heating Hemorrhage High-Dose Rate Brachytherapy Histology Hospitals Image Impotence Incontinence Industrialization Infrastructure Institution Intervention Ionizing radiation Lesion Local Therapy Localized Disease Location Magnetic Resonance Imaging Mainstreaming Malignant Neoplasms Malignant neoplasm of prostate Maps Methods Microscopic Modality Monitor Morbidity - disease rate Necrosis Needles Normal tissue morphology Operative Surgical Procedures Organ Outcome PSA screening Pathology Patient observation Patients Pattern Performance Physicians Population Positioning Attribute Positron-Emission Tomography Procedures Prostate Prostate Ablation Prostate Cancer therapy Prostatectomy Prostatic Diseases Radiation Radiation therapy Radical Prostatectomy Radiosurgery Rectum Research Research Personnel Research Proposals Robotics Role Safety Shapes Stains System Techniques Technology Therapeutic Thermal Ablation Therapy Time Tissues Transducers Translational Research Transrectal Ultrasound Ultrasonic Therapy Ultrasonics Ultrasonography United States Update Urethra Ursidae Family Validation Work acute care base bone cancer diagnosis cohort contrast enhanced cost design dosimetry effective therapy elastography experience experimental study high risk image guided image registration imaging probe implanted sensor improved in silico in vivo in vivo evaluation individualized medicine innovation instrumentation interstitial man men minimally invasive neurovascular non-invasive imaging optimal treatments preservation procedure cost programs prostate cancer risk radiation effect real time monitoring rectal response side effect skills standard care standard of care surgical risk targeted treatment three-dimensional modeling treatment duration treatment optimization treatment planning tumor ultrasound ultrasound ablation

项目摘要

ABSTRACT Prostate cancer is the leading cancer diagnosis and the second leading cause of death in men, affecting one of every six men in the United States. Radiation therapy or surgery are considered the gold standard of treatment modalities for prostate cancer for organ confined disease with generally excellent outcomes, but can result in incontinence, impotence, rectal bleeding and urethral burning. Procedure costs, complete procedure duration, and therapy delivery duration remain issues. Recent advances in multi-parametric MRI and registered biopsy techniques can identify regions of dominant intraprostatic lesions (DIL) to stage and target tumors. In consideration of an alternative to ionizing radiation or prostatectomy and their associated morbidity, recent clinical studies have demonstrated the potential role of thermal ablative techniques. Although promising, these interventional technologies have limited control of the shape and extent of the ablation zone, require multiple or overlapping insertions, often with unnecessary complications. Image-guided HIFU produces multiple small ablation zones and require repositioning of focus to increase volume, but targeting regions immediately adjacent to the rectum or in the anterior prostate is difficult, MRI guided systems require complex and costly infrastructure, and long treatment durations. Intervening normal tissues, gas, and bone are problematic. There are inherent characteristics of currently applied ablation systems that (i) limit their ability to deliver truly conformal destruction of focal disease while minimizing damage to the rectum or neurovascular bundle (NVB), (ii) require significantly long procedure times, and/or (iii) are complex, at limited number of centers, and require expensive infrastructure. Proposed minimally invasive interstitial needle high-intensity ultrasound applicators with highly conformal and penetrating heating patterns, coupled with 3D tracked ultrasound image guidance, treatment planning, intraprocedure therapy monitoring, can be combined to provide an ideal mechanism for conformable precise thermal surgery in prostate. The objective of this project is development of an image- guided interstitial ultrasound ablation system combined with MP-MRI to US image registration, electromagnetic tracking, and biopsy maps for truly 3D controllable and conformal thermal ablation for treatment of both early stage localized and identified high-risk prostate cancer, which is faster and more practical than existing technologies. Unlike HIFU, our device is placed directly into the target under image guidance to treat disease focally without affecting other tissues, with a much shorter 510(k) FDA clearance path. Our approach and technology will provide sophisticated, highly-integrated 3D conformal therapy which is readily disseminated and is practical for mainstream acute care hospitals and outpatient surgery centers. We propose to develop a short duration treatment, precisely targeted therapy for prostate cancer with less side effects than radiation or surgery. The major goal of the proposed project is to complete an ultrasound image guided ultrasound ablation system to treat prostate cancer and performance validation in FDA GLP study.

摘要