TY - JOUR
T1 - HAMAMATSU-ICG study
T2 - Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema
AU - Akita, Shinsuke
AU - Unno, Naoki
AU - Maegawa, Jiro
AU - Kimata, Yoshihiro
AU - Fukamizu, Hidekazu
AU - Yabuki, Yuichiro
AU - Shinaoka, Akira
AU - Sano, Masaki
AU - Kawasaki, Yohei
AU - Fujiwara, Tadami
AU - Hanaoka, Hideki
AU - Mitsukawa, Nobuyuki
N1 - Funding Information:
The present clinical trial plans to be conducted under funding from Hamamatsu Photonics K.K. This work was supported in part by the project ?Assessment of the utility of indocyanine green fluorescent lymphography in diagnosing lymphoedema? from Japan Agency for Medical Research and Development; JMA-CCT-A-2704 (awarded to NU).
Funding Information:
The present clinical trial plans to be conducted under funding from Hamamatsu Photonics K.K . This work was supported in part by the project “Assessment of the utility of indocyanine green fluorescent lymphography in diagnosing lymphoedema” from Japan Agency for Medical Research and Development ; JMA-CCT-A-2704 (awarded to NU).
Publisher Copyright:
© 2020 The Authors
PY - 2020/9
Y1 - 2020/9
N2 - Introduction: Secondary lymphoedema of the extremities is an important quality-of-life issue for patients who were treated for their malignancies. Indocyanine green (ICG) fluorescent lymphography may be helpful for assessing lymphoedema and for planning lymphaticovenular anastomosis (LVA). The objective of the present clinical trial is to confirm whether or not ICG fluorescent lymphography using the near-infrared monitoring camera is useful for assessing the indication for LVA, for the identification of the lymphatic vessels before the conduct of LVA, and for the confirmation of the patency of the anastomosis site during surgery. Methods and analysis: This trial is a phase III, multicentre, single-arm, open-label clinical trial to assess the efficacy and safety of ICG fluorescent lymphography when assessing and treating lymphoedema of patients with secondary lymphoedema who are under consideration for LVA. The primary endpoint is the identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery. The secondary endpoints are 1) the sensitivity and specificity of dermal back flow determined by ICG fluorescent lymphography as compared with 99mTc lymphoscintigraphy—one of the standard diagnostic methods and 2) the usefulness of ICG fluorescent lymphography when confirming the patency of the anastomosis site after LVA. Ethics and dissemination: The protocol for the study was approved by the Institutional Review Board of each institution. The trial was filed for and registered at the Pharmaceuticals and Medical Devices Agency in Japan. The trial is currently on-going and is scheduled to end in June 2020. Trial registration number: jRCT2031190064; Pre-results.
AB - Introduction: Secondary lymphoedema of the extremities is an important quality-of-life issue for patients who were treated for their malignancies. Indocyanine green (ICG) fluorescent lymphography may be helpful for assessing lymphoedema and for planning lymphaticovenular anastomosis (LVA). The objective of the present clinical trial is to confirm whether or not ICG fluorescent lymphography using the near-infrared monitoring camera is useful for assessing the indication for LVA, for the identification of the lymphatic vessels before the conduct of LVA, and for the confirmation of the patency of the anastomosis site during surgery. Methods and analysis: This trial is a phase III, multicentre, single-arm, open-label clinical trial to assess the efficacy and safety of ICG fluorescent lymphography when assessing and treating lymphoedema of patients with secondary lymphoedema who are under consideration for LVA. The primary endpoint is the identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery. The secondary endpoints are 1) the sensitivity and specificity of dermal back flow determined by ICG fluorescent lymphography as compared with 99mTc lymphoscintigraphy—one of the standard diagnostic methods and 2) the usefulness of ICG fluorescent lymphography when confirming the patency of the anastomosis site after LVA. Ethics and dissemination: The protocol for the study was approved by the Institutional Review Board of each institution. The trial was filed for and registered at the Pharmaceuticals and Medical Devices Agency in Japan. The trial is currently on-going and is scheduled to end in June 2020. Trial registration number: jRCT2031190064; Pre-results.
KW - Indocyanine green fluorescent lymphography
KW - Lymphaticovenular anastomosis
KW - Secondary lymphoedema
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U2 - 10.1016/j.conctc.2020.100595
DO - 10.1016/j.conctc.2020.100595
M3 - Article
AN - SCOPUS:85086854188
VL - 19
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
SN - 2451-8654
M1 - 100595
ER -