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Trial Title:
Optical Biopsy to Improve the Diagnosis of Kidney Cancer
NCT ID:
NCT02073110
Condition:
Kidney Cancer
Conditions: Official terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Conditions: Keywords:
Kidney cancer
Renal mass
Small renal mass
Optical Coherence Tomography
OCT
Diffuse Reflectance Spectroscopy
DRS
Optical Biopsy
OB
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Percutaneous Optical Biopsy (OCT and DRS)
Arm group label:
≥ 18 years, solid enhancing renal mass suspected for RCC
Summary:
Data from the American Cancer Society shows a 70% increase in incidence of kidney and
renal pelvis cancer between 2000 and 2010. This increase is attributed to small renal
masses (SRM) that are incidentally discovered by abdominal radiological imaging. However,
30% of resected SRMs appear benign on histological examination. Conventional biopsy is
currently used to provide pathological information prior to resection. However, its
non-diagnostic value is high, up to 33% in SRMs, showing the need for diagnostic
improvement.
The investigators have shown that optical biopsy (OB) can differentiate malignant from
benign tissue and tumor subtypes. However, translation to the clinic requires a phase 2
clinical study. The investigators will use an OB probe that can be combined with a needle
puncture during classical biopsy procedures, additionally providing real time micro-scale
images containing quantitative information about tissue properties. The investigators are
convinced that OB will greatly improve the diagnosis of renal tumor pathology.
Detailed description:
Rationale:
Renal biopsies can be used in patients with renal mass lesions to diagnose whether it
concerns a malignant or benign mass. In case of malignancy, surgery will be the following
step. However, 7 to 33% of biopsies are non-diagnostic, what can result in unnecessary
surgery (even up to 30% in small renal masses). The investigators think that optical
biopsy (OB), a new diagnostic tool based on the absorption en reflection of light in
tissues, reduces the non-diagnostic biopsy rate. This could have a direct impact on the
quality of life of the patients that are therefore scheduled for an unnecessary surgical
procedure. Also, concerns about overtreatment have led to the concept of focal therapy, a
selective patient tailored nephron sparing surgical or ablation technique of a lesion,
reducing lifetime morbidity and side effects without compromising life expectancy. For
this novel form of treatment, accurate identification, grading and demarcation of a
lesion is crucial and OB is the ideal platform to provide this approach to an improved
cure.
Objectives:
Primary
- The accuracy of DRS and OCT in the diagnostic of renal malignancy
Secondary
- The accuracy of DRS and OCT in the diagnostic of renal malignancy and in
distinguishing among the 3 main RCC subtypes
- The accuracy of the combination of the DRS and OCT
Study design:
This is a prospective, observational, multi-centre in-vivo study.
Study population:
Patients ≥ 18 years of age, with a solid enhancing renal mass suspected for renal cell
carcinoma (RCC) and candidates for active (surgical) treatment of the renal mass.
Intervention:
Patients will receive an ultrasound guided percutaneous OB followed by a Core biopsy (CB)
during the same procedure. The planned institutional surgical protocol will be followed
irrespective of the results of OB and CB. During surgery (radical/partial,
open/laparoscopic, percutaneous ablation) a new set of DRS and OCT measurements of the
tumor and normal tissue will be performed.
Main study parameters/endpoints:
1. To determine the accuracy of OB to differentiate renal tumor pathology from benign
tissue by means of minimal invasive quantitative DRS and OCT.
2. To determine the differentiation capability of OCT this combined technique to
distinguish between the three most common RCC sub-types.
3. To determine whether OB is a good alternative to the percutaneous biopsy for
diagnosing renal cancer.
Criteria for eligibility:
Study pop:
Patients ≥ 18 years of age, with a solid enhancing renal mass suspected for renal cell
carcinoma (RCC) and candidates for active (surgical) treatment of the renal mass.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age ≥ 18 years
- Solid, enhancing mass on cross sectional imaging suspect for RCC
- Scheduled for total or partial nephrectomy or for laparoscopic cryoablation.
- Signed informed consent
Exclusion Criteria:
- Patients with a renal mass that are not candidates for active treatment will be
excluded from the study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Free University Medical Center
Address:
City:
Amsterdam
Zip:
1081 HV
Country:
Netherlands
Status:
Not yet recruiting
Contact:
Last name:
RJA van Moorselaar, MD. PhD.
Phone:
+31204440272
Email:
Rja.vanmoorselaar@vumc.nl
Facility:
Name:
Academic Medical Center
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
MP Laguna Pes, MD. PhD.
Phone:
+31205666928
Email:
m.p.lagunapes@amc.uva.nl
Contact backup:
Last name:
Peter Wagstaff, MD.
Phone:
+31205666493
Email:
p.g.wagstaff@amc.uva.nl
Investigator:
Last name:
Peter Wagstaff, MD
Email:
Sub-Investigator
Start date:
August 2013
Lead sponsor:
Agency:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Agency class:
Other
Source:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02073110