Feasibility of lymphoscintigraphy and sentinel node biopsy in patients with renal cell carcinoma

• Conditions: kidney cancer; renal cell carcinoma; 10038364

• Registration Number: NL-OMON30718
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility of a) preoperative lymphoscintigraphy and b) intraoperative<br /><br>detection and sampling of the sentinel node.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Excised sentinel nodes will be examined for activation and/or downregulation of<br /><br>immune cells in comparison to non-sentinel nodes.</p><br>