Intraoperative molecular imaging of colorectal lung metastases with SGM-101: a feasibility study

Ruben P.J. Meijer, Hidde A. Galema, the SGM-CLM study group, Robin A. Faber, Okker D. Bijlstra, Alexander P.W.M. Maat, Françoise Cailler, Jerry Braun, Stijn Keereweer, Denise E. Hilling, Jacobus Burggraaf, Alexander L. Vahrmeijer, Merlijn Hutteman*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

Purpose: 

Metastasectomy is a common treatment option for patients with colorectal lung metastases (CLM). Challenges exist with margin assessment and identification of small nodules, especially during minimally invasive surgery. Intraoperative fluorescence imaging has the potential to overcome these challenges. The aim of this study was to assess feasibility of targeting CLM with the carcinoembryonic antigen (CEA) specific fluorescent tracer SGM-101. 

Methods: 

This was a prospective, open-label feasibility study. The primary outcome was the number of CLM that showed a true positive fluorescence signal with SGM-101. Fluorescence positive signal was defined as a signal-to-background ratio (SBR) ≥ 1.5. A secondary endpoint was the CEA expression in the colorectal lung metastases, assessed with the immunohistochemistry, and scored by the total immunostaining score. 

Results: 

Thirteen patients were included in this study. Positive fluorescence signal with in vivo, back table, and closed-field bread loaf imaging was observed in 31%, 45%, and 94% of the tumors respectively. Median SBRs for the three imaging modalities were 1.00 (IQR: 1.00–1.53), 1.45 (IQR: 1.00–1.89), and 4.81 (IQR: 2.70–7.41). All tumor lesions had a maximum total immunostaining score for CEA expression of 12/12. 

Conclusion: 

This study demonstrated the potential of fluorescence imaging of CLM with SGM-101. CEA expression was observed in all tumors, and closed-field imaging showed excellent CEA specific targeting of the tracer to the tumor nodules. The full potential of SGM-101 for in vivo detection of the tracer can be achieved with improved minimal invasive imaging systems and optimal patient selection. 

Trial registration: 

The study was registered in ClinicalTrial.gov under identifier NCT04737213 at February 2021.

Original languageEnglish
JournalEuropean Journal of Nuclear Medicine and Molecular Imaging
DOIs
Publication statusE-pub ahead of print - 8 Aug 2023

Bibliographical note

Publisher Copyright:
© 2023, The Author(s).

Funding:
The study drug SGM-101 was provided by SurgiMab.

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