Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma.
Minimal invasive endoscopic treatment for Upper Urinary Tract Urothelial Carcinoma (UUT-UC) has been accepted as a treatment option instead of radical nephroureterectomy for patients with low grade, low stage disease. For this reason, information on tumour stage and grade is important for a clinical decision. Until now,diagnostic ureterorenoscopy combined with histology/cytology is the gold standard. Unfortunately, histology/cytology is often inconclusive.
Optical Coherence Tomography is a new high resolution imaging technique that has potential to provide the urologist real time per-operative information of grade and stage of the disease.
In this study the investigators aim to establish in vivo sensitivity and specificity of OCT in the diagnosis of Upper Urinary Tract Urothelial Carcinoma. Secondary objectives are inter-observer variability of 1300 nm OCT in the diagnosis of UUT-UC and optical properties of cancerous and healthy ureter and collecting system tissue in vivo in humans.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| optical coherence tomography | Experimental | A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography | Device | Single Optical Coherence Tomography measurement of upper urinary tract tumour taken during ureterorenoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of 1300nm OCT in grading and staging UUT-UC | Only a single OCT measurement will be done during surgery. This measurement will take a maximum of 10 minutes, including preparation of the OCT device | up to 10 minutes |
| Specificity of 1300nm OCT in grading and staging UUT-UC | Only a single OCT measurement will be done during surgery. This measurement will take a maximum of 10 minutes, including preparation of the OCT device | up to 10 minutes |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Optical properties of cancerous and healthy ureter and collecting system tissue | only a single OCT measurement will be done during surgery. This measurement will take a maximum of 10 minutes, including preparation of the OCT device | up to 10 minutes |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jean J. de la Rosette, MD PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Amsterdam | North Holland | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23954585 | Result | Bus MT, Muller BG, de Bruin DM, Faber DJ, Kamphuis GM, van Leeuwen TG, de Reijke TM, de la Rosette JJ. Volumetric in vivo visualization of upper urinary tract tumors using optical coherence tomography: a pilot study. J Urol. 2013 Dec;190(6):2236-42. doi: 10.1016/j.juro.2013.08.006. Epub 2013 Aug 13. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Optical Coherence Tomography | Device | A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s) |
|
|
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
Not provided
Not provided