2012-01-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/648964摘要：過去這幾年來核能研究所詹美齡博士領導的團隊所研發的乳房專用正子攝影儀(INER BreastPET)系統已逐漸由雛型系統而進入與產業界之銜接。初步假體測試結果也有空間解析度可達1.6 mm FWHM 之優異表現。與國外Naviscan 廠牌之產品有不分軒輊的成效。然而，在下一步進入臨床使用甚至技術轉移給業界成為生醫產業明日之星之前有必要在國內進行初步之臨床試驗，一方面驗證其規格、品質，另一方面也讓操作之技術人員在人機界面上提出更多user-friendly 的改進建議。接下來是實地上在乳癌患者作測試以與常規之正子斷層掃描作一比較對，提出其使用上之優劣點，並與常規正子掃描作一診斷上實用性之初步比對。藉此，可找出未來這個儀器真正在臨床上使用之強項，更可作為業界技轉之根據與基礎。本計畫構想上略分為兩年來進行，第一年度是讓我們的放射師熟悉整個儀器之操作，並用假體作為測試的基本架構，一方面驗證核研所過去所作的研究結果，另一方面提出進一步改進人機界面的可能性。同時，在這一年內我們要提出臨床試驗之申請，由於這是國內這類儀器首次提出申請，當可預期困難度會很大。我們期望可在一年內取得IRB 通過並開始少數受檢者之測試。第二年才是真正進行臨床人體試驗。我們將利用在臨床上已證實是乳癌且進行正子掃描之病患50 名作平行試驗比較兩者所能偵檢病變之大小、個數等特性。對照組包括20-25 名自費參加健康檢查接受全身正子掃描檢查之女性病患以及20-25 名罹患其他癌症接受全身正子掃描檢查診斷或追蹤之女性病患，皆需徵得她們同意。最後這份研究報告將可提供詹博士領導團隊之參考作為進一步改進以及技轉前的參考。完成此項人體試驗以及機台之驗證後，應可消除業界對本系統之疑慮，可以促進早日進行技轉，作為國內生醫儀器廠商未來開發之重點儀器，造福國人甚至銷售全世界。<br> Abstract: In the past several years, the R&D team of Institute of Nuclear Energy Research(INER) lead by Dr. Jan ML has successfully produced a dedicated breast positron emissiontomography scanner, the INER BreatPET. The prototype has passed through the stringenttesting and safety check up by the Electronic Testing Center, Taiwan. The tested spatialresolution of 1.6 mm FWHM is nearly equal to the capability of an FDA approved PEM, theNaviscan PEM Flex Solo II.Before going to be transferred to the industry for further registration and production, itis important to have a preliminary testing in a medical center in Taiwan. This is for thequality check up and also familiarity of this instrument by the daily practicing technologists.We also need to test this instrument in a small group of breast cancer patients to compare thedetection efficacy with the whole body PET scan. The technologists can provide furthersuggestions during the daily use of this brand new machine. They can make the INER teamfurther polish this new machine and help find out the niche of this dedicated machine.We will proceed this project as a two year proposal. In the first year, our team memberwill get acquainted with the operation of this new machine. We will use the phantom studyto reproduce the performing characteristics done in INER. We will tried our best to make itmore user-friendly. Besides, we will apply the clinical trial to the IRB for the permission inthe first year. We expected that there will be some difficulty in the approval of this trial.After the approval we will try several cases as our pilot test. The main work of clinical trialswill be in the second year. We planned to collect 50 cases of breast cancer in our study tocompare the sensitivity, specificity and accuracy with whole body PET scanner. The controlgroup will include 20-25 female customers coming to the hospital for general health checkup with whole body PET as their selected option. The other 20-25 control subjects will bethose who have cancers other than breast cancer and come to the PET center for workup orfollow up of their clinical condition by whole body PET scans. They will sign consensusbefore join in the clinical trial.The final report of this clinical trial can be used for the references by the INERBreastPET R&D team. Also, after this trial, we can further demonstrate the feasibility of thissystem in applying to the daily, routine, clinical situation for the industry. This will be thenext medical instrument candidate that can be produced in Taiwan and exported worldwide.乳癌乳房專用正子攝影儀核研乳房正子攝影儀臨床試驗breast cancerdedicated breast positron emission tomographyPEMINER BreastPETclinical trial