Clinical trial NCT02497599: Intraoperative Dual-modality Imaging in Renal Cell Carcinoma
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Carcinoma, Renal Cell
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Fluorescent signal at time of surgery
timeFrame: During surgery
Secondary outcomes:
measure: 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
timeFrame: 4 weeks
measure: Blood levels of the dual-labeled antibody
timeFrame: 60, 120 and 180 minutes after injection and 4 and 7 days after injection
measure: Optimal dose of the dual-labeled antibody preparation
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Peter FA Mulders, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Wim JG Oyen, M.D. PhD
role: STUDY_DIRECTOR
References: