成果報告書詳細
管理番号20140000000463
タイトル*平成25年度中間年報 「がん超早期診断・治療機器の総合研究開発 超低侵襲治療機器システムの研究開発:高精度X線治療機器の研究開発 放射線治療の低侵襲性および治療効果を高める放射線増感剤の開発 」
公開日2014/7/26
報告書年度2013 - 2013
委託先名学校法人東京理科大学 株式会社バイタル 学校法人北里研究所 国立大学法人東京農工大学
プロジェクト番号P10003
部署名バイオテクノロジー・医療技術部
和文要約
英文要約Title:Comprehensive Research and Development of Medical Equipment for Extremely Early Detection and Treatment of Cancer / Research and Development of Super-Minimally Invasive Treatment System : Research and Development of Highly Precise X-ray Treatment Equipment / Development of radiosensitization drug for enhancement of treatment effect and low invasiveness of radiation therapy. (FY2013-FY2014) FY2013 Annual Report

1. Safety trials of SQAP
Four beagle dogs were employed for safety trials. A control (n=1) and a SQAP administered group in which the SQAP dosage was 5 mg/kg,25 mg/kg,and 50 mg/kg (n=1, respectively) were prepared. SQAP was administered by bolus or drip through a 22G catheter indwelling at cephalic vein. Hematologic tests and biochemical examination of blood were conducted. In addition, observation of change in general condition of dogs were performed.
  Clear abnormality in blood examination values and abnormality in clinical observation were not seen in results. However, in dogs with the SQAP dosage of 25 mg/kg and 50 mg/kg, angialgia were observed. Thus, SQAP was diluted with saline and administered by a drip infusion protocol that resulted in no observation of angialgia. Angialgia was not observed in the dog of SQAP dosage of 5 mg/kg even in bolus infusion. The safety trial is still on-going. However, from the above results, it is understood that the main adverse effect of SQAP is angialgia suggesting that a diluted drip infusion administration is required for the clinical cases.

2. Animal clinical trials combining SQAP and Tomotherapy
Animal clinical trials were conducted. SQAP was administered on a total of 4 days. Irradiation amount was reduced to 1/2 of typical normal dose according to each animal patient. One month after irradiation, hematologic tests, biochemical examination of blood, and CT examinations were conducted, and evaluation of tumor size, occurrence of or non-occurrence of metastasis, and adverse effects were conducted.
  At present, testing of synovial sarcoma, meningeoma, chondrosarcoma, and ceruminous adenocarcinoma in four animal patient cases are in progress. Even though irradiation amount has been halved, clinical symptoms due to tumors in all cases have disappeared. No adverse events were observed due to SQAP administration. At the present stage, no significant decline in volume of the tumors are observed. However, arterial distribution of the tumors have decreased (suggesting necrosis). Accordingly, it is clear that a method of determining effect of SQAP by simply measuring tumor diameter is insufficient, and further detailed discussion is necessary.

3. Effect of SQAP on radiation therapy
Radiation therapy sensitized by SQAP was evaluated using 18F labeled fluorodeoxy glucose (18F-FDG) and positron emission tomography (PET). Animal patient is a beagle dog having a tumor. Prior to radiation therapy, a PET imaging with 18F-FDG was conducted to evaluate survival activity of the tumor. For radiation therapy, a high pressure stereotactic radiosurgery unit was employed. 2 hours prior to radiation therapy, continuous intravenous infusion of 4 mg/kg of SQAP was conducted on the dog. Radiation dosage employed for therapy was 2 gun irradation of 4.5 x 2.5 Gy, once a week.
  Accordingly, the tumor tissue radiation ratio (standard uptake value, SUV) in accordance with FDG uptake of the mammary gland tumor in PET examination prior to radiation therapy was 6 at initial imaging and 4 at final imaging. PET examination conducted 2 weeks after radiation therapy showed a SUV of 5 at initial imaging and a decline to 3 at final imaging. These results suggest that SQAP show a radiation therapy increasing effect in combination with radiation therapy and an effect of decreasing survival activity of the tumor.
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