Beta Camera and Laparoscopic Probe for Surgical Cancer Removal.

用于癌症手术切除的 Beta 相机和腹腔镜探头。

• 批准号: 7328574
• 负责人: FARHAD DAGHIGHIAN
• 金额: $ 10万
• 依托单位: INTRA MEDICAL IMAGING, LLC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2008-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7328574
• 关键词: Abdomen; Address; Background Radiation; Beds; Beta Particle; Biological; Breast; Breast Melanoma; Breast-Conserving Surgery; Caliber; Cancer Detection; Cancer Patient; Cancerous; Ceramics; Certification; Cessation of life; Clinical Trials; Condition; Coupled; Coupling; Data; Dependence; Deposition; Detection; Development; Devices; Distant; Ensure; Excision; Fiber; Fiber Optics; Gamma Rays; Hand; Image; Institutes; Intra-abdominal; Invasive; Isotopes; Label; Laparoscopy; Lead; Left; Localized; Malignant Neoplasms; Malignant neoplasm of abdomen; Malignant neoplasm of prostate; Marketing; Measures; Membrane; Methods; Microscopic; Neoplasm Metastasis; Operative Surgical Procedures; Organ; Patients; Phase; Plastics; Positron; Problem Solving; Process; Prostate; Radio; Radioactive; Range; Rate; Recovery; Recurrence; Relapse; Research; Resected; Resolution; Safety; Solid; Solutions; Standards of Weights and Measures; Surface; Surgeon; Surveys; Technology; Temperature; Testing; Time; Tissues; Touch sensation; Tracer; Travel; Tube; Vision; Work; base; breast lumpectomy; cancer cell; cancer surgery; design; detector; fluorodeoxyglucose; improved; in vivo; intraoperative imaging; malignant breast neoplasm; melanoma; milligram; millimeter; novel; photomultiplier; prevent; prototype; psychologic; research and development; research study; solid state; tumor; two-dimensional; voltage

DESCRIPTION (provided by applicant): The recent development of the Solid State Photo-Multiplier (SSPM) has created an unprecedented opportunity to develop a safe, highly sensitive and compact beta camera for use during cancer surgery, and a Laparoscopic beta probe for intra-abdominal cancer detection. We will build these devices, incorporate them into our marketed intra-operative control unit, test them with phantoms and pursue safety certifications for their eventual use in clinical trials during the Phase II. Significance: Surgery is the only certain cure for cancer; however, its curative ability is compromised by the potential of leaving behind microscopic traces of the tumor, known as margins. In breast cancer, for example, there is a 20% recurrence rate after breast-conserving surgery (lumpectomy) due to missed margins. A beta camera capable of surveying the tumor bed, intraoperatively, and imaging visually undetectable, minute amounts of cancer cells, could significantly reduce recurrence rate of many cancers such as melanoma, breast and prostate, and increase survival. In addition, it may enable more breast cancer patients to become candidates for breast saving lumpectomies and improve the psychological recovery from breast cancer. A Laparoscopic beta probe would give a new "vision" to the surgeon and facilitate detection and complete removal of abdominal cancer in a minimally invasive manner. Background: F-18 atoms emit positrons (beta rays) that in turn generate gamma rays. Gamma rays travel tens of cm in tissue, while beta rays have a range of~2mm. Beta emitting isotopes are ideal for intraoperative imaging since background radiation would not interfere with identification of margins. Until now, beta cameras have suffered from one of two serious flaws that prevent their use in cancer surgery 1. The thin shielding required for positron detection provides insufficient insulation from the high voltage photomultiplier tubes (PMTs), or 2. The long fiber-optic coupling used to separate the high voltage from the patient greatly reduces sensitivity. Preliminary Data: We have previously developed a beta camera with the resolution and sensitivity to detect minute (5 mg) cancer deposits. Over the last year we have tested various configurations of SSPMs and scintillators; our research shows that SSPMs have higher sensitivity than photomultiplier tubes while operating at ~ 50 volts. They are also very small (1x1 mm). We conducted preliminary testing, in which we measured an absolute efficiency of 15% for a small plastic scintillator directly coupled to an SSPM, as opposed to 0.2% for an identical scintillator coupled fiber-optically to a PMT. We have built a prototype of the SSPM based beta camera in an small scale and demonstrated its feasibility. Research and Development Plan: We will build the camera with a sheet of red plastic scintillator and a 2 dimensional array of SSPMs. We will also build a dual detector beta probe in a 5 mm diameter for laparoscopy using SSPMs and plastic scintillators. We will then study the effect of temperature variance from 25 to 37 oC, and investigate various methods to compensate for temperature dependence. Once these issues have been addressed we will optimize the sensitivity of the camera, and perform characterization experiments. During the design process we will implement all applicable electrical and biological safety standards. Then we will determine limits of tumor detection of this camera with realistic phantoms. In Phase II we will conduct trials with our long-time collaborators at the John Wayne Cancer Institute on melanoma and breast cancer patients, at Cornell on prostate cancer, and at Memorial Sloan Kettering in abdominal Laparoscopic cancer detection.

描述（由申请人提供）：固态照相型（SSPM）的最新发展创造了前所未有的机会，以开发一种安全，高度敏感和紧凑的β摄像头，以便在癌症手术期间使用，以及用于腹腔内癌症癌症检测的腹腔镜β探针。我们将构建这些设备，将它们纳入我们市场上销售的术中控制单元，用幻影对其进行测试，并在第二阶段的临床试验中最终使用安全认证。意义：手术是唯一的癌症治疗方法；然而，它的治愈能力因留下肿瘤的微观痕迹（称为边缘）的潜力而损害了它。例如，在乳腺癌中，由于缺席的边缘，乳腺癌手术（肿块切除术）后的复发率为20％。能够在术中对肿瘤床进行测量的β摄像头，并在视觉上无法检测到的微量癌细胞，可以显着降低许多癌症的复发率，例如黑色素瘤，乳腺癌和前列腺，并增加生存率。此外，它可能使更多的乳腺癌患者成为节省乳房切除术并改善乳腺癌心理康复的候选者。腹腔镜β探针将为外科医生提供新的“视力”，并以微创的方式促进并完全去除腹癌。背景：F-18原子会发出原子（β射线），从而产生伽玛射线。伽玛射线在组织中传播数十厘米，而β射线的范围约为2mm。 β发射同位素是术中成像的理想选择，因为背景辐射不会干扰边缘的识别。到目前为止，β摄像机遭受了两个严重缺陷之一，阻止了它们在癌症手术中的使用1。正电子检测所需的薄屏蔽可提供不足的隔热性，这些绝缘层无法从高电压光塑料管（PMTS）或2中。用于将高电压与患者的巨大造成敏感性分开的长纤维耦合。 初步数据：我们以前已经开发了一个具有分辨率和敏感性来检测分钟（5 mg）癌症沉积物的beta摄像头。在过去的一年中，我们测试了SSPM和闪烁体的各种配置。我们的研究表明，SSPM的灵敏度比光电倍增管的灵敏度更高，而在约50伏。它们也很小（1x1毫米）。我们进行了初步测试，其中我们测量了直接与SSPM耦合的小型塑料闪烁体的绝对效率为15％，而相同闪烁体的纤维偶联器与PMT相同的闪烁剂偶联器的绝对效率为0.2％。我们已经构建了基于SSPM的Beta摄像头的原型，并证明了其可行性。 研发计划：我们将使用一张红色的塑料闪光灯和2维的SSPM构建相机。我们还将使用SSPM和塑料闪烁体的直径为5毫米的双重探测器β探针构建双重检测器β探针。然后，我们将研究25至37 OC的温度方差的影响，并研究各种方法以补偿温度依赖性。解决这些问题后，我们将优化相机的灵敏度，并执行表征实验。在设计过程中，我们将实施所有适用的电气和生物安全标准。然后，我们将确定具有逼真的幻影的肿瘤检测限制。在第二阶段，我们将在约翰·韦恩癌症研究所（John Wayne Cancer Institute fil of Geran癌和乳腺癌患者），前列腺癌中的康奈尔（Cornell）以及腹部腹腔镜癌症检测中的纪念斯隆（Sloan kettering）与我们的长期合作者进行试验。