NCT03699332

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 13, 2019

Status Verified

September 1, 2019

Enrollment Period

2.2 years

First QC Date

October 5, 2018

Last Update Submit

September 12, 2019

Conditions

Peritoneal CarcinomatosisColorectal CancerCarcinomaNeoplasmsGastrointestinal Cancer

Keywords

image guided surgeryCRSHIPECFluorescenceAntibodies, monoclonal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    4 weeks

  • Blood levels of the dual-labeled antibody

    60, 120 and 180 minutes after injection and 4 and 7 days after injection

  • Optimal dose of the dual-labeled antibody preparation

    4 weeks

Study Arms (1)

Intraoperative multi-modality imaging

EXPERIMENTAL

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 injectionRadiation: SPECT/CT scanProcedure: CRS extended with dual-modality imaging

Interventions

Indium-111-DOTA-Labetuzumab-IRDye800CW injectionDRUG

Tracer injection

Intraoperative multi-modality imaging
SPECT/CT scanRADIATION

Abdominal and thoracic SPECT/CT scan.

Intraoperative multi-modality imaging
CRS extended with dual-modality imagingPROCEDURE

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

Intraoperative multi-modality imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboudumc

Nijmegen, 6525 GA, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35551444DERIVED

MeSH Terms

Conditions

Peritoneal NeoplasmsColorectal NeoplasmsCarcinomaNeoplasmsGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Abdominal NeoplasmsNeoplasms by SiteDigestive System NeoplasmsDigestive System DiseasesPeritoneal DiseasesIntestinal NeoplasmsGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • JHW de Wilt, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

FMK Elekonawo, MD

CONTACT

0031 24 3619097Fortune.Elekonawo@radboudumc.nl

JM de Gooyer, MD

CONTACT

0031 24 3667244Jan-Marie.Gooyer@radboudumc.nl

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

December 1, 2018

Primary Completion

March 1, 2021

Study Completion

September 1, 2021

Last Updated

September 13, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)