kidney cancer renal cell carcinoma
Conditions
Interventions
On the day before surgery or at least four hours pre-operatively,
99mTc-nanocolloid will be injected at the primary tumour site. The injection
will be performed percutaneously under ultrasound or CT
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-cT2) 2. No metastatic disease on imaging and clinical examination (cN0, cM0) 3. Age: 18 to 65 years 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. Blood counts: Leucocytes > 3.0 x 109/l, platelets > 100 x 109/l, hemoglobin > 6.0 mmol/l. 8. Serum bilirubin, ASAT, ALAT and creatinin within 1.5 times of upper limit of reference values of laboratory. 9. 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. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility of a) preoperative lymphoscintigraphy and b) intraoperative detection and sampling of the sentinel node. | — |
Secondary
| Measure | Time frame |
|---|---|
| Excised sentinel nodes will be examined for activation and/or downregulation of immune cells in comparison to non-sentinel nodes. | — |
Countries
Netherlands
Outcome results
None listed