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Intraoperative Dual-modality Imaging in Renal Cell Carcinoma

NCT02497599 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-29

No results posted yet for this study

Summary

Intraoperative tumor localization and resection can be enhanced using intraoperative fluorescence imaging and radiodetection. Girentuximab specifically recognizes carbonic anhydrase IX expressed on \> 95% of renal cell carcinoma (RCC). Therefore Indium-111-DOTA-girentuximab-IRDye800CW is a perfect dual-labeled antibody for dual-modality image-guided surgery in RCC.

The aim of this study is to assess the feasibility and safety of intraoperative dual-modality imaging with Indium-111-DOTA-girentuximab-IRDye800CW in renal cell carcinoma patients.

Conditions

  • Carcinoma, Renal Cell

Interventions

DRUG

Indium-111-DOTA-Girentuximab-IRDye800CW

Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy

RADIATION

SPECT/CT

4 or 5 days after tracer injection a SPECT/CT of the abdomen will be acquired.

PROCEDURE

Intraoperative dual-modality imaging

7 days after dual-labeled girentuximab injection standard of care surgery will be performed extended with the use of dual-modality imaging.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Peter FA Mulders, M.D. PhD · Radboud University Medical Center

  • Wim JG Oyen, M.D. PhD · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2021-12-31
Completion
2022-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02497599 on ClinicalTrials.gov