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The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with hematuria compared to the traditional four-phase CT (control).
Responsible centers Oslo University Hospital, Aker. Division of Radiology and Nuclear medicine.
Study type: Prospective clinical trial
Study design: One sample paired proportion, non-inferiority study with a 7.5% non-inferiority limit.
Investigational product: One phase nephrographic CT (experimental arm) vs. Four-phase CT (control arm)
Objective:The primary objective is to evaluate whether one-phase nephrographic CT (experimental) is sufficient to detect urothelial cell carcinoma in patients with asymptomatic macroscopic hematuria compared to the traditional four-phase CT (control).
Primary endpoints: The difference in accuracy between the experimental- and control arm.
there will also be a secondary reading in order to asses interobserver variability for both the experimental and the control arm
Sample size: 250 patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nephrographic phase CT | Experimental | the nephrographic phase will be evaluated alone by a radiologist blinded to the remaining series |
|
| gold standard | Active Comparator | all series (unenhanced, corticomedullary, nephrographic and excretory phase) will be evaluated by a radiologist not involved in the experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT | Diagnostic Test | the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| accuracy for detecting urothelial cell carcinomas | the accuracy of the experimental arm will not be worse than the accuracy of the control CT by a margin of more than 7.5% | all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of UCC diagnosis after one year |
| Measure | Description | Time Frame |
|---|---|---|
| false negative rate | The difference in false negative rates | all examinations are evaluated immediately after the CT examination |
| false positive rate | The difference in false positive rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik Rud | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0524 | Norway |
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| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| D002292 | Carcinoma, Renal Cell |
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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One sample, paired, non-inferiority study with a 7.5% non-inferiority limit. Each patient undergo the experimental CT and the control CT
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one investigator evaluates the experimental arm a second investigator evaluates the control arm without knowledge of the other
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| all examinations are evaluated immediately after the CT examination |
| renal cell carcinoma detection rates | The detection rates in the two arms | all examinations are evaluated immediately after the CT examination. Follow-up ascertainment of RCC diagnosis after one year |
| Area under the curve (AUC) | the difference in AUC of the two arms | all examinations are evaluated immediately after the CT examination |
| predictive values | The difference in the predictive values of the two arms | all examinations are evaluated immediately after the CT examination |
| Detection or urinary calculi | The difference in detection of the two arms | all examinations are evaluated immediately after the CT examination |
| Detection of Bosniak cyst | The difference in detection in the two arms | all examinations are evaluated immediately after the CT examination |
| Interobserver variability | The agreement and variability between primary and secondary readers | all examinations are evaluated immediately after the CT examination |
| D000230 |
| Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D052878 | Urolithiasis |