Intraoperative Dual-modality Imaging in Renal Cell Carcinoma
NCT ID: NCT02497599
Last Updated: 2021-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2015-06-30
2022-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Indium-111-DOTA-Girentuximab-IRDye800CW
Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy
SPECT/CT
4 or 5 days after tracer injection a SPECT/CT of the abdomen will be acquired.
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.
Interventions
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Indium-111-DOTA-Girentuximab-IRDye800CW
Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy
SPECT/CT
4 or 5 days after tracer injection a SPECT/CT of the abdomen will be acquired.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Performance status: Karnofsky 70 %
* Being fit for surgery
* Minimum age 18 years
* Signed informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Peter FA Mulders, M.D. PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Wim JG Oyen, M.D. PhD
Role: STUDY_DIRECTOR
Radboud University Medical Center
Locations
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Radboudumc
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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13071988
Identifier Type: -
Identifier Source: org_study_id
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