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資料3-2 インドシアニングリーン［353KB］ (20 ページ)
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| 公開元URL | https://www.mhlw.go.jp/stf/shingi2/0000198856_00042.html |
| 出典情報 | 医薬・生活衛生局が実施する検討会 医療上の必要性の高い未承認薬・適応外薬検討会議（第68回 7／4）《厚生労働省》 |
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１１．参考文献一覧
1） 米国添付文書：SPY AGENT GREEN（Novadaq Technologies ULC）
2） 英国添付文書：Verdye 5 mg/mL injection（Diagnostic Green Limited）
3） 独国添付文書：VERDYE（Diagnostic Green GmbH）
4） 仏国添付文書：INFRACYANINE 25 mg/10 ml（SERB）
5） 加国添付文書：SPY AGENT GREEN（Novadaq Technologies ULC）
6） 豪州添付文書：SPY AGENT GREEN（Stryker Australia Pty Ltd）
7） Frumovitz et al. Near-infrared fluorescence for detection of sentinel lymph nodes in women with
cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial.
Lancet Oncol. 2018; 19: 1394-403.
8） Paley et al. A prospective investigation of fluorescence imaging to detect sentinel lymph nodes
at robotic-assisted endometrial cancer staging. Am J Obstet Gynecol 2016; 215: 117 e1–7.
9） Rossi et al. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial
cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017;18:
384-92.
10） Rozenholc et al. Green versus blue: Randomized controlled trial comparing indocyanine green
with methylene blue for sentinel lymph node detection in endometrial cancer. Gynecol Oncol.
2019;153: 500-4.
11） Backes et al. Prospective clinical trial of robotic sentinel lymph node assessment with isosulfane
blue (ISB) and indocyanine green (ICG) in endometrial cancer and the impact of ultrastaging
(NCT01818739). Gynecol Oncol. 2019;153(3):496-9.
12） Lührs et al. Combining Indocyanine Green and Tc99-nanocolloid does not increase the detection
rate of sentinel lymph nodes in early stage cervical cancer compared to Indocyanine Green alone.
Gynecol Oncol. 2020; 156: 335-40.
13） Kataoka et al. The importance of para-aortic lymph nodes in sentinel lymph node mapping for
endometrial cancer by using hysteroscopic radio-isotope tracer injection combined with
subserosal dye injection: Prospective study. Gynecol Oncol. 2016; 140: 400-4.
14） Tanaka et al. The detection of sentinel lymph nodes in laparoscopic surgery can eliminate
systemic lymphadenectomy for patients with early stage endometrial cancer. Int J Clin Oncol.
2018; 23: 305-13.
15） Tanaka et al. The detection of sentinel lymph nodes in laparoscopic surgery for uterine cervical
cancer using 99m-technetium-tin colloid, indocyanine green, and blue dye. J Gynecol Oncol.
2017; 28: e13.
16） Ruscito et al. Sentinel Node Mapping in Cervical and Endometrial Cancer: Indocyanine Green
Versus Other Conventional Dyes—A Meta-Analysis. Ann Surg Oncol 2016; 23: 3749-56.
20
1） 米国添付文書：SPY AGENT GREEN（Novadaq Technologies ULC）
2） 英国添付文書：Verdye 5 mg/mL injection（Diagnostic Green Limited）
3） 独国添付文書：VERDYE（Diagnostic Green GmbH）
4） 仏国添付文書：INFRACYANINE 25 mg/10 ml（SERB）
5） 加国添付文書：SPY AGENT GREEN（Novadaq Technologies ULC）
6） 豪州添付文書：SPY AGENT GREEN（Stryker Australia Pty Ltd）
7） Frumovitz et al. Near-infrared fluorescence for detection of sentinel lymph nodes in women with
cervical and uterine cancers (FILM): a randomised, phase 3, multicentre, non-inferiority trial.
Lancet Oncol. 2018; 19: 1394-403.
8） Paley et al. A prospective investigation of fluorescence imaging to detect sentinel lymph nodes
at robotic-assisted endometrial cancer staging. Am J Obstet Gynecol 2016; 215: 117 e1–7.
9） Rossi et al. A comparison of sentinel lymph node biopsy to lymphadenectomy for endometrial
cancer staging (FIRES trial): a multicentre, prospective, cohort study. Lancet Oncol. 2017;18:
384-92.
10） Rozenholc et al. Green versus blue: Randomized controlled trial comparing indocyanine green
with methylene blue for sentinel lymph node detection in endometrial cancer. Gynecol Oncol.
2019;153: 500-4.
11） Backes et al. Prospective clinical trial of robotic sentinel lymph node assessment with isosulfane
blue (ISB) and indocyanine green (ICG) in endometrial cancer and the impact of ultrastaging
(NCT01818739). Gynecol Oncol. 2019;153(3):496-9.
12） Lührs et al. Combining Indocyanine Green and Tc99-nanocolloid does not increase the detection
rate of sentinel lymph nodes in early stage cervical cancer compared to Indocyanine Green alone.
Gynecol Oncol. 2020; 156: 335-40.
13） Kataoka et al. The importance of para-aortic lymph nodes in sentinel lymph node mapping for
endometrial cancer by using hysteroscopic radio-isotope tracer injection combined with
subserosal dye injection: Prospective study. Gynecol Oncol. 2016; 140: 400-4.
14） Tanaka et al. The detection of sentinel lymph nodes in laparoscopic surgery can eliminate
systemic lymphadenectomy for patients with early stage endometrial cancer. Int J Clin Oncol.
2018; 23: 305-13.
15） Tanaka et al. The detection of sentinel lymph nodes in laparoscopic surgery for uterine cervical
cancer using 99m-technetium-tin colloid, indocyanine green, and blue dye. J Gynecol Oncol.
2017; 28: e13.
16） Ruscito et al. Sentinel Node Mapping in Cervical and Endometrial Cancer: Indocyanine Green
Versus Other Conventional Dyes—A Meta-Analysis. Ann Surg Oncol 2016; 23: 3749-56.
20