European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2025
Phase 2 Dose-Ranging Trial of VGT-309 for Molecular Imaging of Cancer during Pulmonary Resection.
СтатьяКлиническое исследование II фазыПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Wright Gavin M, Egan A J Matthew, Mack Jane M, Clatworthy Sharnel, Anja Rafaela, Scribner Curtis L, Santini John T, Bensen Eric S
Аннотация
OBJECTIVES: VGT-309 (abenacianine) is being evaluated as an intraoperative molecular imaging (IMI) agent. This phase 2, open-label, dose-ranging study evaluated efficacy and safety in participants undergoing surgical resection of suspicious or proven cancer in the lung.
METHODS: Adults who consented to participate in the study were assigned to treatment with VGT-309 at 0.05, 0.16, or 0.32 mg/kg dose administered 2-6 or 12-36 hours presurgery. Intraoperative tumour fluorescence intensity and contrast were assessed to inform efficacy across dosing parameter. Ex vivo imaging of surgical specimens was performed before and after histopathology.
RESULTS: Twenty-seven participants received VGT-309. No lesions were visualized in participants receiving 0.05 mg/kg or 0.16 mg/kg administered 2-6 hours presurgery. Near-infrared (NIR) imaging after treatment with 0.16 mg/kg 12-36 hours presurgery identified 3 of 4 lesions from 3 of 4 participants. Sixteen participants were administered 0.32 mg/kg; 6 dosed 2-6 hours and 10 dosed 12-36 hours presurgery. IMI identified 6 of 7 lesions from 5 of 6 participants dosed 2-6 hours presurgery, while 8 of 11 lesions from 7 of 10 participants dosed 12-36 hours presurgery displayed intraoperative fluorescence. A single suspected unexpected serious adverse reaction of liver transaminitis resolved within 30 days. Otherwise, VGT-309 was safe and well tolerated in this study.
CONCLUSIONS: Results support the safety and efficacy of VGT-309 in identifying cancer in the lung with 0.16 mg/kg day-before surgery dosing and 0.32 mg/kg at either dosing schedule.
CLINICAL TRIAL REGISTRATION NUMBER: ACTRN12621000301864.
METHODS: Adults who consented to participate in the study were assigned to treatment with VGT-309 at 0.05, 0.16, or 0.32 mg/kg dose administered 2-6 or 12-36 hours presurgery. Intraoperative tumour fluorescence intensity and contrast were assessed to inform efficacy across dosing parameter. Ex vivo imaging of surgical specimens was performed before and after histopathology.
RESULTS: Twenty-seven participants received VGT-309. No lesions were visualized in participants receiving 0.05 mg/kg or 0.16 mg/kg administered 2-6 hours presurgery. Near-infrared (NIR) imaging after treatment with 0.16 mg/kg 12-36 hours presurgery identified 3 of 4 lesions from 3 of 4 participants. Sixteen participants were administered 0.32 mg/kg; 6 dosed 2-6 hours and 10 dosed 12-36 hours presurgery. IMI identified 6 of 7 lesions from 5 of 6 participants dosed 2-6 hours presurgery, while 8 of 11 lesions from 7 of 10 participants dosed 12-36 hours presurgery displayed intraoperative fluorescence. A single suspected unexpected serious adverse reaction of liver transaminitis resolved within 30 days. Otherwise, VGT-309 was safe and well tolerated in this study.
CONCLUSIONS: Results support the safety and efficacy of VGT-309 in identifying cancer in the lung with 0.16 mg/kg day-before surgery dosing and 0.32 mg/kg at either dosing schedule.
CLINICAL TRIAL REGISTRATION NUMBER: ACTRN12621000301864.