The objective of the study is to determine the feasibility of lymphatic mapping in non-metastatic, clinically node negative RCC including preoperative lymphoscintigraphy and intraoperative sentinel node identification using patent blue dye and a…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of a) preoperative lymphoscintigraphy and b) intraoperative
detection and sampling of the sentinel node.
Secondary outcome
Excised sentinel nodes will be examined for activation and/or downregulation of
immune cells in comparison to non-sentinel nodes.
Background summary
Nowadays, sentinel node biopsy is widely used for nodal staging of melanoma and
breast cancer. Other investigators performed sentinel node biopsy in urological
malignancies, head and neck cancer and gastrointestinal cancer.
Currently, little is known about the lymphatic drainage of renal cell
carcinoma. This may have implications for the fact that the role of lymph node
dissection in renal cell carcinoma has been controversial for decades.
Next to the importance for lymph node dissection, the sentinel node has been
recognized as the lymph node in which priming of the immune reaction takes
place. There are detailed investigations in melanoma, an immunogenic malignancy
like renal cell carcinoma. Sentinel lymph nodes, being the first nodes to
receive lymph from a primary tumour and the preferential site of initial tumour
metastases, are intensively exposed to the bioactive products of tumour cells
and other associated cells. This makes them ideal for studies of the factors
that determine selective tissue susceptibility to metastases.
Study objective
The objective of the study is to determine the feasibility of lymphatic mapping
in non-metastatic, clinically node negative RCC including preoperative
lymphoscintigraphy and intraoperative sentinel node identification using patent
blue dye and a gamma ray detection probe
Study design
Feasibility study. To gain sufficient experience with the injection technique
and intraoperative sampling during a feasibility study, a total number of 10
patients will be included in this study.
No statistical analysis is required.
Intervention
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 guidance. Subsequently,
lymphoscintigraphy will be performed at 20 minutes, 2 hours and 4 hours after
tracer injection. During the last scintigraphy, emission-transmission SPECT
will be performed. These images will be matched with CT to determine the
anatomical localization of the sentinel node. The operation will be planned in
the afternoon or the following day depending on logistic aspects.
Patent blue dye (small volume of 0.5 ml) will be injected near the primary
tumour as soon as the kidney is exposed at surgery. A standard nephrectomy will
be performed. Blue stained lymph nodes will be dissected and the hand-held
gamma probe will be used to identify radioactive lymph nodes.
Study burden and risks
Apart from an extra time of 2 1/2 hours and a lymphoscintigraphy the additional
risks associated with participation (intratumoral injection and intraoperative
sampling) are minor in comparison to the risk of nephrectomy (standard therapy)
Plesmanlaan 121
1066 CX Amsterdam
Nederland
Plesmanlaan 121
1066 CX Amsterdam
Nederland
Listed location countries
Age
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
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 | NL16017.031.07 |