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

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 - Intraoperative dual-modality imaging in renal cell carcinoma

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43587

Enrollment

Registered

2015-01-12

Start date

2015-06-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

clear cell renal cell carcinoma Kidney cancer

Interventions

- Day 0: Patients receive a single intravenous dose of Indium-111-DOTA-girentuximab-IRDye800CW (100 MBq). - Day 4 or 5 SPECT/CT images will be acquired. - Day 7: At day 7 surgery will be planned. T

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)