Multi-modality Imaging in Peritoneal Carcinomatosis of Colorectal Origin (MMIPC)

Radboud University Medical Center

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Neoplasms; Gastrointestinal Cancer; Carcinoma; Peritoneal Carcinomatosis; Colorectal Cancer

Treatments: Radiation: SPECT/CT scan; Procedure: CRS extended with dual-modality imaging; Drug: Indium-111-DOTA-Labetuzumab-IRDye800CW injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03699332

NL57505.091.16

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 29 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of peritoneal carcinomatosis of colorectal origin
• Scheduled for cytoreductive surgery and HIPEC.
• Age over 18 years
• Signed informed consent

Exclusion criteria

• Any medical condition present that in the opinion of the investigator will affect patients clinicals status
• Administration of a radionuclide within 10 physical half-lives prior to study enrollment
• Pregnancy or lactation
• Patients with very high (>500ng/ml serum CEA levels
• Known CEA negative tumor

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Intraoperative multi-modality imaging

Experimental group

Description:

Patients receive a single intravenous dose of Indium-111-DOTA-Labetuzumab-IRDye800CW. At day 4 or 5 after antibody injection a SPECT/CT scan will be acquired. At day 6 or 7 standard of care cytoreductive surgery will be performed. This will be extended with the use of dual-modality imaging.

Treatment:

Procedure: CRS extended with dual-modality imaging

Drug: Indium-111-DOTA-Labetuzumab-IRDye800CW injection

Radiation: SPECT/CT scan