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

Recruiting

• Conditions: clear cell renal cell carcinoma; Kidney cancer; 10038364; 10038430; 10038365

• Registration Number: NL-OMON43587
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 22

Inclusion Criteria

- Clinical diagnosis of primary clear cell renal cell carcinoma or a recurrent or metastatic clear cell renal cell carcinoma lesion planned for surgery;- Age over 18 years;- Signed informed consent

Exclusion Criteria

- A known subtype other than clear cell RCC;- Administration of a radioisotope within 10 physical half lives prior to study enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Fluorescence intensity and radioactive signal scored by two different<br /><br>surgeons.<br /><br>- Safety measures of dual-labeled antibody injection<br /><br>- Feasibility of dual-modality imaging.<br /><br>- Dual-labeled tracer measurements:<br /><br>* - Tumor to normal ratio<br /><br>* - Tracer accumulation in tumor and normal tissue: percentage of the injected<br /><br>dose per gram tissue, %ID/g.<br /><br>* - Correlation of tracer uptake to histology, CAIX expression and tumor<br /><br>viability.<br /><br>- Optimal dose of the dual-labeled antibody preparation<br /><br>- Pharmacokinetics of dual-labeled girentuximab: clearance. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable. </p><br>