Multi-modality Imaging in Peritoneal Carcinomatosis of Colorectal Origin

NCT ID: NCT03699332

Last Updated: 2019-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2021-09-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Indium-111-DOTA-Labetuzumab-IRDye800CW injection

Intervention Type: DRUG

Tracer injection

SPECT/CT scan

Intervention Type: RADIATION

Abdominal and thoracic SPECT/CT scan.

CRS extended with dual-modality imaging

Intervention Type: PROCEDURE

cytoreductive surgery will be performed extended with the use of dual-modality imaging.

Interventions

Indium-111-DOTA-Labetuzumab-IRDye800CW injection

Tracer injection

Intervention Type: DRUG

SPECT/CT scan

Abdominal and thoracic SPECT/CT scan.

Intervention Type: RADIATION

CRS extended with dual-modality imaging

cytoreductive surgery will be performed extended with the use of dual-modality imaging.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Cancer Society

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JHW de Wilt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboudumc

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

FMK Elekonawo, MD

Role: CONTACT

Fortune.Elekonawo@radboudumc.nl

0031 24 3619097

JM de Gooyer, MD

Role: CONTACT

Jan-Marie.Gooyer@radboudumc.nl

0031 24 3667244

Facility Contacts

Jan-Marie de Gooyer, MD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35551444 (View on PubMed)

Other Identifiers

NL57505.091.16

Identifier Type: -

Identifier Source: org_study_id