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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03699332
Recruitment Status : Unknown
Verified September 2019 by Radboud University Medical Center.
Recruitment status was:  Recruiting
First Posted : October 9, 2018
Last Update Posted : September 13, 2019
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Colorectal Cancer Carcinoma Neoplasms Gastrointestinal Cancer Drug: Indium-111-DOTA-Labetuzumab-IRDye800CW injection Radiation: SPECT/CT scan Procedure: CRS extended with dual-modality imaging Phase 1 Phase 2

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Indium

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intraoperative multi-modality imaging
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Fluorescent signal at time of surgery [ Time Frame: During cytoreductive surgery ]
    Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No


Secondary Outcome Measures :
  1. 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 [ Time Frame: 4 weeks ]
    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

  2. Blood levels of the dual-labeled antibody [ Time Frame: 60, 120 and 180 minutes after injection and 4 and 7 days after injection ]
    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)

  3. Optimal dose of the dual-labeled antibody preparation [ Time Frame: 4 weeks ]
    Optimal dose of dual-labeled antibody for dual modality image guided surgery


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699332


Contacts
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Contact: FMK Elekonawo, MD 0031 24 3619097 Fortune.Elekonawo@radboudumc.nl
Contact: JM de Gooyer, MD 0031 24 3667244 Jan-Marie.Gooyer@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Jan-Marie de Gooyer, MD         
Sponsors and Collaborators
Radboud University Medical Center
Dutch Cancer Society
Investigators
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Principal Investigator: JHW de Wilt, MD, PhD Radboud University Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT03699332    
Other Study ID Numbers: NL57505.091.16
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radboud University Medical Center:
image guided surgery
CRS
HIPEC
Fluorescence
Antibodies, monoclonal
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Carcinoma
Peritoneal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Labetuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents