Intraoperative Dual-modality Imaging in Renal Cell Carcinoma

September 23, 2021 updated by: Radboud University Medical Center

A Phase 1 Study to Evaluate the Safety and Feasibility of Intraoperative Detection of Clear Cell Renal Cell Carcinoma Using Indium-111-DOTA-girentuximab-IRDye800CW

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In oncologic surgery complete tumor resection is important for treatment outcome and patient survival. 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. 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 concept has been shown in preclinical studies with mice and the investigators will translate this to the clinic.

Eligible patients with renal cell carcinoma scheduled for (partial) nephrectomy will receive dual-labeled girentuximab 7 days before surgery. At day 4 or 5 a SPECT/CT of the abdomen will be obtained. 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-girentuximab-IRDye800CW in renal cell carcinoma.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of clear cell renal cell carcinoma planned for surgery, (partial) nephrectomy
  • Performance status: Karnofsky 70 %
  • Being fit for surgery
  • Minimum age 18 years
  • Signed informed consent

Exclusion Criteria:

  • A known subtype other than clear cell RCC
  • Any medical condition present that in the opinion of the investigator will affect patients' clinical status.
  • Administration of a radioisotope within 10 physical half lives prior to study enrollment
  • Pregnancy and lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoperative dual-modality imaging
Patients receive a single intravenous dose of Indium-111-DOTA-Girentuximab-IRDye800CW. At day 4 or 5 after antibody injection a whole body planar scan and SPECT/CT scan will be acquired. At day 7 standard of care (partial) nephrectomy will be performed. This will be extended with the use of dual-modality imaging.
Drug: Indium-111-DOTA-Girentuximab-IRDye800CW
Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy
Other Names:
  • Dual-labeled girentuximab
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.
Other Names:
  • Fluorescence and radioguided surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluorescent signal at time of surgery
Time Frame: During surgery
Can the tumor be identified by the fluorescent signal? Yes/No. Can the tumor be distinguished from normal tissue? Yes/No
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
The number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0 will be scored.
4 weeks
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).
60, 120 and 180 minutes after injection and 4 and 7 days after injection
Optimal dose of the dual-labeled antibody preparation
Time Frame: 4 weeks
Tumor to background ratio will be evaluated for each dose.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Peter FA Mulders, M.D. PhD, Radboud University Medical Center
  • Study Director: Wim JG Oyen, M.D. PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

July 13, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13071988

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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