Intraoperative Dual-modality Imaging in Renal Cell Carcinoma

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT02497599
Collaborator
(none)
30
1
1
82
0.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
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
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Fluorescent signal at time of surgery [During 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

    1. 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 [4 weeks]

      The number of participants with grade 3 or 4 Adverse Events according to CTCAE v4.0 will be scored.

    2. Blood levels of the dual-labeled antibody [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).

    3. Optimal dose of the dual-labeled antibody preparation [4 weeks]

      Tumor to background ratio will be evaluated for each dose.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Radboudumc Nijmegen Netherlands

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radboud University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02497599
    Other Study ID Numbers:
    • 13071988
    First Posted:
    Jul 14, 2015
    Last Update Posted:
    Sep 29, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 29, 2021