Demonstrate the ability of OCT to distinguish malignant renal tissue from benign (normal) renal tissue by means of attenuation-coefficient.
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study outcome is the attenuation-coefficient measured by OCT of the 2
tissue types: normal renal parenchyma and malignant (RCC) tissue.
Secondary outcome
None
Background summary
Differentiation between benign and malignant (small) renal mass by radiological
means is difficult and therefore up to 30% of surgery for renal mass is
unnecessary. Optical Coherence Tomography (OCT) is a technique that may
contribute to improvement of the accuracy of such renal mass.
OCT is an imaging technique analogous to ultrasound exept for the fact that it
employs light- in stead of soundwaves. OCT measures the effective reflection of
light in dephth of a tissue sample. When a ray of light penetrates into a
tissue sample the intensity of the light decreases due to scattering and
absorption of light by different structures in the tissue sample (such as
nuclei and organelles).
Our hypothesis is that OCT can differentiate malignant from benign tissue by
objectivating the decrease of light intensity per milimeter, since the
attenuation of light intensity is hypothetically higer in malignant tissue due
to the larger size and amount of nuclei and organelles whch results in a higer
degree of scattering and absorption of light. This attenuation is objectivated
as the attenuation-coefficient (or µt).
Study objective
Demonstrate the ability of OCT to distinguish malignant renal tissue from
benign (normal) renal tissue by means of attenuation-coefficient.
Study design
This study is an observational cohort-study with patients scheduled for surgery
for a renal mass suspect for malignancy.
Study burden and risks
OCT is harmless for human beings since it is light-based with a wavelength of
1300 nm.
Since all measurements take place during surgery there are no extra visits
necessary.
The operation time is slightly prolonged (max. 5 minutes with a (partial)
nephrectomy usually taking about 2 hours of operation time).
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
> 18 yrs
solid, enhancing renal mass, suspect for malignancy
scheduled for (open or laparoscopic) nephrectomy or partial nephrectomy
signed informed consent
Exclusion criteria
cystic renal mass
Design
Recruitment
Medical products/devices used
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 | NL32723.018.10 |