To investigate site and distribution of sentinel nodes in clinically non metastatic kidney cancer.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
*Main endpoint: Lymphatic drainage not localized locoregional
retroperitoneally.
Secondary outcome
*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.
Background summary
The aim of the study is to analyze lymphatic drainage from kidney tumours and
to describe the distribution of sentinel nodes. Our hypothesis is that sentinel
nodes are not exclusively localized locoregional retroperitioneally.
Study objective
To investigate site and distribution of sentinel nodes in clinically non
metastatic kidney cancer.
Study design
Diagnostic study.
Intervention:
*Pre-operative lymphoscintigraphy, after injection of 240 MBq of
99mTechnetium-nannocolloid. Planar images after 20 minutes, 2 hours and 4
hours. SPECT/CT after 4 hours.
*Intra-operative sentinel node excision (during the *standard* nephrectomy)
after localization with patent blue and/or gamma probe.
Intervention
Lymphoscintigraphy after injection of the radiopharmaceutical. During
nephrectomy, a sentinel node biopsy will be performed.
Study burden and risks
Burden and risks: Radioactivity dose is the same as in other malignancies and
does not have any risks. Patent blue is registered in the Netherlands, allergic
reactions are extremely rare and airway and intravenous access are secured
during administration. Injection might cause a kidney bleeding, but since
patients will be operated afterwards it will not have serious implications.
Sentinel nodes will not be excised if excision will lead to a substantial
longer operation time (more than half an hour) or a increase in operation risk.
This means that retroperitoneal sentinel nodes will be excised, as will be
superficial supraclavicular sentinel nodes, but sentinel nodes in the thoracic
cavity will be left in place.
Possible benefits: It is not clear whether early detection of sentinel node
metastasis can provide survival benefit. Patients might have a benefit of
optimal staging and possibly early resection in case of a small localized
metastasis in the sentinel node.
plesmanlaan 121
1066 CX Amsterdam
NL
plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26406.031.08 |