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Intraoperative Dual-modality Imaging in Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02497599
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

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
Carcinoma, Renal Cell Drug: Indium-111-DOTA-Girentuximab-IRDye800CW Radiation: SPECT/CT Procedure: Intraoperative dual-modality imaging 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
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 : June 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : August 2018


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 Name: 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 Name: Fluorescence and radioguided surgery




Primary Outcome Measures :
  1. 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


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 [ Time Frame: 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 [ 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).

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497599


Contacts
Contact: Marlène Hekman, Drs. 0031243619097 marlene.hekman@radboudumc.nl

Locations
Netherlands
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: MCH Hekman, MD    0031243619097    marlene.hekman@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Peter FA Mulders, M.D. PhD Radboud University
Study Director: Wim JG Oyen, M.D. PhD Radboud University

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02497599     History of Changes
Other Study ID Numbers: 13071988
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs