kidney tumour renal cell carcinoma
Conditions
Interventions
Lymphoscintigraphy after injection of the radiopharmaceutical. During
nephrectomy, a sentinel node biopsy will be performed.
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Localized parenchymal tumor of the kidney not exceeding 10 cm (cT1-cT3) 2. No metastatic disease on imaging and clinical examination (cN0, cM0) 3. Age: 18 years and older 4. Life expectancy > 3 months 5. WHO performance status 0 or 1 and fit for surgery 6. Written informed consent obtained from the patient after having been informed about the objectives of the study and the medication used. 7. No prior systemic treatment with biological response modifiers, tyrosine-kinase inhibitors, monoclonal antibodies or chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Parenchymal kidney tumor larger than 10 cm 2. Clinically metastatic disease or at imaging 3. Patients in whom surgery is no option due to comorbidity 4. Current cardiovascular disease, hematopoetic, pulmonary, hepatic or renal dysfunction or WHO performance status > 1. 5. Previous immunotherapy, therapy with tyrosine-kinase inhibitors, monoclonal antibodies or chemotherapy. 6. Corticosteroid and/ or other immunosuppressive therapies. 7. Prior malignancies. In case of NED the period should be > 5 years. 8. Preganancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Main endpoint: Lymphatic drainage not localized locoregional retroperitoneally. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Secondary endpoints: Intra-operative mapping and detection, activation or downregulation of immune cells in sentinel nodes, cancer specific survival and morbidity, complication rate of surgery, sensitivity of the technique and stage migration. | — |
Countries
Netherlands
Outcome results
None listed