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

Primary Purpose

Peritoneal Carcinomatosis, Colorectal Cancer, Carcinoma

Status
Unknown status
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Indium-111-DOTA-Labetuzumab-IRDye800CW injection
SPECT/CT scan
CRS extended with dual-modality imaging
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peritoneal Carcinomatosis focused on measuring image guided surgery, CRS, HIPEC, Fluorescence, Antibodies, monoclonal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • RadboudumcRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intraoperative multi-modality imaging

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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)
Optimal dose of the dual-labeled antibody preparation
Optimal dose of dual-labeled antibody for dual modality image guided surgery

Full Information

First Posted
October 5, 2018
Last Updated
September 12, 2019
Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT03699332
Brief Title
Multi-modality Imaging in Peritoneal Carcinomatosis of Colorectal Origin
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Carcinomatosis, Colorectal Cancer, Carcinoma, Neoplasms, Gastrointestinal Cancer
Keywords
image guided surgery, CRS, HIPEC, Fluorescence, Antibodies, monoclonal

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraoperative multi-modality imaging
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Indium-111-DOTA-Labetuzumab-IRDye800CW injection
Intervention Description
Tracer injection
Intervention Type
Radiation
Intervention Name(s)
SPECT/CT scan
Intervention Description
Abdominal and thoracic SPECT/CT scan.
Intervention Type
Procedure
Intervention Name(s)
CRS extended with dual-modality imaging
Intervention Description
cytoreductive surgery will be performed extended with the use of dual-modality imaging.
Primary Outcome Measure Information:
Title
Fluorescent signal at time of surgery
Description
Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No
Time Frame
During cytoreductive surgery
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
4 weeks
Title
Blood levels of the dual-labeled antibody
Description
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)
Time Frame
60, 120 and 180 minutes after injection and 4 and 7 days after injection
Title
Optimal dose of the dual-labeled antibody preparation
Description
Optimal dose of dual-labeled antibody for dual modality image guided surgery
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FMK Elekonawo, MD
Phone
0031 24 3619097
Email
Fortune.Elekonawo@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
JM de Gooyer, MD
Phone
0031 24 3667244
Email
Jan-Marie.Gooyer@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JHW de Wilt, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan-Marie de Gooyer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35551444
Citation
de Gooyer JM, Elekonawo FMK, Bremers AJA, Boerman OC, Aarntzen EHJG, de Reuver PR, Nagtegaal ID, Rijpkema M, de Wilt JHW. Multimodal CEA-targeted fluorescence and radioguided cytoreductive surgery for peritoneal metastases of colorectal origin. Nat Commun. 2022 May 12;13(1):2621. doi: 10.1038/s41467-022-29630-9.
Results Reference
derived

Learn more about this trial

Multi-modality Imaging in Peritoneal Carcinomatosis of Colorectal Origin

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