Multi-modality Imaging in Peritoneal Carcinomatosis of Colorectal Origin

Colorectal Cancer Clinical Trial

— MMIPC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03699332
• Other study ID #: NL57505.091.16
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2018
• Est. completion date: September 2021

Study information

• Verified date: September 2019
• Source: Radboud University
• Contact: FMK Elekonawo, MD
• Phone: 0031 24 3619097
• Email: Fortune.Elekonawo[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: September 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Neoplasms
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

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

Radiation:
• SPECT/CT scan
Abdominal and thoracic SPECT/CT scan.

Procedure:
• CRS extended with dual-modality imaging
cytoreductive surgery will be performed extended with the use of dual-modality imaging.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluorescent signal at time of surgery	Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No	During cytoreductive surgery
Secondary	Safety of dual-labeled antibody (labetuzumab) as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0	Safety of dual-labeled antibody injection as assessed by the number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0	4 weeks
Secondary	Blood levels of the dual-labeled antibody	Blood samples will be measured for radioactivity in a gamma counter at different timepoints after injection. This will be expressed as percentage injected dose per gram (%ID/g)	60, 120 and 180 minutes after injection and 4 and 7 days after injection
Secondary	Optimal dose of the dual-labeled antibody preparation	Optimal dose of dual-labeled antibody for dual modality image guided surgery	4 weeks