Colorectal Cancer Clinical Trial
Official title:
A Phase I/II Study to Evaluate the Safety and Feasibility of Multi-modality Imaging Using Indium-111-DOTA-labetuzumab-IRDye800CW in Patients With Peritoneal Carcinomatosis of Colorectal Origin
Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Labetuzumab specifically recognizes CEA which is is expressed on > 95% of colorectal cancers.. Therefore Indium-111-DOTA-labetuzumab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in peritoneal carcinomatosis of colorectal cancer.
In oncologic surgery complete tumor resection is important for treatment outcome and patient
survival. When performing cytoreductive surgery (CRS) for peritoneal carcinomatosis of
colorectal origin it can sometimes be difficult to distinguish tumor deposits from adhesions
and scar tissue. Intraoperative tumor localization and resection can be enhanced using
intraoperative imaging techniques (e.g. targeted radioguided or fluorescence guided surgery).
A powerful synergy can be achieved by combining radiotracers (e.g. Indium-111) and optical
tracers (e.g. IRDye 800CW) conjugated to an antibody against a tumor-associated antigen.
Labetuzumab specifically recognises CEA which is expressed on > 95% of all colorectal
cancers. Therefore Indium-111-DOTA-labetuzumab-IRDye800CW is a perfect dual-labeled antibody
for dual-modality image-guided surgery in peritoneal carcinomatosis of colorectal origin. The
concept has been shown in preclinical studies with mice and the investigators will translate
this to the clinic.
Eligible patients with peritoneal carcinomatosis of colorectal origin scheduled for CRS +
HIPEC will receive dual-labeled labetuzumab 6-7 days before surgery. At day 4 or 5 a SPECT/CT
of the abdomen and thorax will be obtained. Cytoreductive surgery at day 7 will be extended
with the use of a near-infrared fluorescence camera and a gamma probe.
The aim of this study is to assess the feasibility and safety of intraoperative dual-modality
imaging with Indium-111-DOTA-labetuzumab-IRDye800CW in peritoneal carcinomatosis of
colorectal cancer.
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