BACKGROUND: Carcinoembryonic antigen is overexpressed in colorectal cancer (CRC), making it an optimal target for fluorescence imaging. A phase I/II study was designed to determine the optimal imaging dose of SGM-101 for intraoperative fluorescence imaging of primary and recurrent CRC. METHODS: Patients were included and received a single dose of SGM-101 at least 24 h before surgery. Patients who received routine anticancer therapy (i.e., radiotherapy or chemotherapy) also were eligible. A dedicated near-infrared imaging system was used for real-time fluorescence imaging during surgery. Safety assessments were performed and SGM-101 efficacy was evaluated per dose level to determine the most optimal imaging dose. RESULTS: Thirty-seven patients with CRC were included in the analysis. Fluorescence was visible in all primary and recurrent tumors. In seven patients, no fluorescence was seen; all were confirmed as pathological complete responses after neoadjuvant therapy. Two tumors showed false-positive fluorescence. In the 37 patients, a total of 97 lesions were excised. The highest mean intraoperative tumor-to-background ratio (TBR) of 1.9 (p = 0.019) was seen in the 10-mg dose. This dose showed a sensitivity of 96%, specificity of 63%, and negative predictive value of 94%. Nine patients (24%) had a surgical plan alteration based on fluorescence, with additional malignant lesions detected in six patients. CONCLUSIONS: The optimal imaging dose was established at 10 mg 4 days before surgery. The results accentuate the potential of SGM-101 and designated a promising base for the multinational phase III study, which enrolled the first patients in June 2019.
BACKGROUND:Carcinoembryonic antigen is overexpressed in colorectal cancer (CRC), making it an optimal target for fluorescence imaging. A phase I/II study was designed to determine the optimal imaging dose of SGM-101 for intraoperative fluorescence imaging of primary and recurrent CRC. METHODS:Patients were included and received a single dose of SGM-101 at least 24 h before surgery. Patients who received routine anticancer therapy (i.e., radiotherapy or chemotherapy) also were eligible. A dedicated near-infrared imaging system was used for real-time fluorescence imaging during surgery. Safety assessments were performed and SGM-101 efficacy was evaluated per dose level to determine the most optimal imaging dose. RESULTS: Thirty-seven patients with CRC were included in the analysis. Fluorescence was visible in all primary and recurrent tumors. In seven patients, no fluorescence was seen; all were confirmed as pathological complete responses after neoadjuvant therapy. Two tumors showed false-positive fluorescence. In the 37 patients, a total of 97 lesions were excised. The highest mean intraoperative tumor-to-background ratio (TBR) of 1.9 (p = 0.019) was seen in the 10-mg dose. This dose showed a sensitivity of 96%, specificity of 63%, and negative predictive value of 94%. Nine patients (24%) had a surgical plan alteration based on fluorescence, with additional malignant lesions detected in six patients. CONCLUSIONS: The optimal imaging dose was established at 10 mg 4 days before surgery. The results accentuate the potential of SGM-101 and designated a promising base for the multinational phase III study, which enrolled the first patients in June 2019.
Authors: Judith A Stibbe; Petra Hoogland; Friso B Achterberg; Derek R Holman; Raoul S Sojwal; Jacobus Burggraaf; Alexander L Vahrmeijer; Wouter B Nagengast; Stephan Rogalla Journal: Mol Imaging Biol Date: 2022-06-28 Impact factor: 3.488
Authors: Thinzar M Lwin; Michael A Turner; Hiroto Nishino; Siamak Amirfakhri; Sophie Hernot; Robert M Hoffman; Michael Bouvet Journal: Biomolecules Date: 2022-05-16
Authors: Feredun Azari; Gregory Kennedy; Elizabeth Bernstein; Constantinos Hadjipanayis; Alexander Vahrmeijer; Barbara Smith; Eben Rosenthal; Baran Sumer; Jie Tian; Eric Henderson; Amy Lee; Quyen Nguyen; Summer Gibbs; Brian Pogue; Daniel Orringer; Cleopatra Charalampaki; Linda Martin; Janos Tanyi; Major Lee; John Y Lee; Sunil Singhal Journal: J Biomed Opt Date: 2021-05 Impact factor: 3.170
Authors: H M Schouw; L A Huisman; H H Boersma; S Kruijff; Y F Janssen; R H J A Slart; R J H Borra; A T M Willemsen; A H Brouwers; J M van Dijl; R A Dierckx; G M van Dam; W Szymanski Journal: Eur J Nucl Med Mol Imaging Date: 2021-10-11 Impact factor: 9.236
Authors: Thinzar M Lwin; Michael A Turner; Siamak Amirfakhri; Hiroto Nishino; Robert M Hoffman; Michael Bouvet Journal: Cells Date: 2022-01-12 Impact factor: 6.600
Authors: Michael A Turner; Thinzar M Lwin; Siamak Amirfakhri; Hiroto Nishino; Robert M Hoffman; Paul J Yazaki; Michael Bouvet Journal: Biomolecules Date: 2021-12-02