Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Mar 4;9(2):zraf045.
doi: 10.1093/bjsopen/zraf045.

Multimodal carcinoembryonic antigen-targeted fluorescence and radio-guided cytoreductive surgery for peritoneal metastases of colorectal origin: single-arm confirmatory trial

Aaya Darai  1 , Jan Marie de Gooyer  1   2 , Sander Ubels  1 , Andreas J A Bremers  1 , Philip R de Reuver  1 , Erik H J G Aarntzen  2 , Iris D Nagtegaal  3 , Mark Rijpkema  2 , Johannes H W de Wilt  1
Affiliations
Clinical Trial

Multimodal carcinoembryonic antigen-targeted fluorescence and radio-guided cytoreductive surgery for peritoneal metastases of colorectal origin: single-arm confirmatory trial

Aaya Darai et al. BJS Open. .

Abstract

Background: Selection of suitable candidates for intraoperative tumour detection and cytoreductive surgery (CRS) combined with hyperthermic intraperitoneal chemotherapy (HIPEC) is important for improving outcomes for patients with colorectal peritoneal metastases. Previous research demonstrated the use of single-photon emission computed tomography (SPECT), intraoperative radiodetection, and near-infrared fluorescence (NIRF)-guided surgery with a dual-labelled 111In-labelled dodecane tetra-acetic acid (DOTA)-labetuzumab-IRDye800CW tracer to detect peritoneal metastases before operation. The aim of this study was to validate these results.

Methods: A single-centre phase II study was conducted to evaluate the safety and feasibility of 111In-labelled DOTA-labetuzumab-IRDye800CW in patients with colorectal peritoneal metastases undergoing CRS-HIPEC. SPECT/computed tomography (CT) was undertaken before surgery, after intravenous administration of 10 mg 111In-labelled DOTA-labetuzumab-IRDye800CW (mean 101.25 MBq). During surgery, radiodetection and NIRF imaging were used for tumour detection. Adverse events were assessed, and tumour-to-background ratios (TBRs) and peritoneal cancer index scores were analysed.

Results: Seven patients were included. No study-related severe adverse events were reported. Imaging before surgery revealed previously undetected metastases in one patient. The mean(standard deviation, s.d.) SPECT/CT peritoneal cancer index score was 3(2), and the intraoperative score was 14(7) (P = 0.032). A total of 52 lesions were removed during CRS, of which 37 were malignant. With NIRF imaging, 34 (92%) of 37 malignant lesions were detectable. Of 52 fluorescent lesions, 4 were false-positive. Mean(s.d.) fluorescence TBR was 3.4(1.8) and mean radiodetection TBR was 4.4(1.4).

Conclusion: This study confirmed the safety and feasibility of multimodal image-guided surgery in patients with peritoneal metastases.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Flow diagram showing patient inclusion CRS, cytoreductive surgery; HIPEC, hyperthermic intraperitoneal chemotherapy.
Fig. 2
Fig. 2
Multimodal imaging of previously undetected lymph node metastases (patient 7) a Retroclavicular node, b para-oesophageal node. SPECT, single-photon emission computed tomography; CT, computed tomography.
Fig. 3
Fig. 3
Mean fluorescence and mean radiosignal TBR per patient Black dots indicate values for individual patients. Median value (bold line), interquartile range (box), and range (error bars) are also shown. TBR, tumour-to-background ratio.
Fig. 4
Fig. 4
In vivo and ex vivo fluorescence detection in peritoneal metastases (patient 1) a Intraoperative near-infrared fluorescence (NIRF) imaging of a metastatic node near the medial colic artery (MCA), b  ex vivo NIRF imaging of suspicious node near the superior mesenteric vein (SMV). From top to bottom: NIR-fluorescence colour overlay, NIR-fluorescence, brightfield.
See this image and copyright information in PMC

References

    1. Rijken A, van de Vlasakker VCJ, Simkens GA, Rovers KP, van Erning FN, Koopman M et al. Primary tumor resection or systemic treatment as palliative treatment for patients with isolated synchronous colorectal cancer peritoneal metastases in a nationwide cohort study. Clin Exp Metastasis 2023;40:289–298 - PMC - PubMed
    1. van Gestel YRBM, Thomassen I, Lemmens VEPP, Pruijt JFM, van Herk-Sukel MPP, Rutten HJT et al. Metachronous peritoneal carcinomatosis after curative treatment of colorectal cancer. Eur J Surg Oncol 2014;40:963–969 - PubMed
    1. Razenberg LG, Lemmens VEPP, Verwaal VJ, Punt CJA, Tanis PJ, Creemers G-J et al. Challenging the dogma of colorectal peritoneal metastases as an untreatable condition: results of a population-based study. Eur J Cancer 2016;65:113–120 - PubMed
    1. Quere P, Facy O, Manfredi S, Jooste V, Faivre J, Lepage C et al. Epidemiology, management, and survival of peritoneal carcinomatosis from colorectal cancer: a population-based study. Dis Colon Rectum 2015;58:743–752 - PubMed
    1. Verwaal VJ, Bruin S, Boot H, van Slooten G, van Tinteren H. 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol 2008;15:2426–2432 - PubMed

Publication types

MeSH terms