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Perfusion Scanning's for Kidney Tumors

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ClinicalTrials.gov Identifier: NCT01971905
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Nessn Azawi, Zealand University Hospital

Brief Summary:
To investigate the ability of perfusion CT/US-scanning to facilitate recognition of different tumour sub-types in small renal masses less than 7 cm by non-invasive imagining technology.

Condition or disease
Kidney Cancer

Detailed Description:

The number of diagnoses of renal cell carcinoma has increased over the past two decades because of the incidental detection of small renal tumours resulting from increased use of computed tomography [1,2]. There are distinct subtypes of renal cell carcinoma (RCC), and the biological aggressiveness and prognoses for these subtypes have been documented. Clear-cell RCC is the most common RCC subtype, followed by papillary RCC, chromophobe RCC and unclassified RCC. Collecting duct carcinoma is a rare and highly malignant type of RCC. Although most enhancing renal masses in adults are RCC, a significant percentage are benign (commonly oncocytoma), and these benign tumours cannot be distinguished from malignant tumours based on our standard imaging technology alone.

Benign primary renal masses include simple renal cysts, psuedotumours, angiomyolipomas, oncocytomas, juxtaglomerular tumours, multilocular cystic nephromas, mesoblastic nephromas and papillary adenomas. In a recent surgical series of 228 patients who underwent partial or radical nephrectomy with lesions ≤4 cm, 26.3% were benign [3]. The relatively high percentage of patients with benign renal cortical neoplasms who undergo surgery highlights the importance of new diagnostic technology in avoiding over-treatment.

Ultrasound (US) and CT scanning guided biopsy is the most commonly used method to diagnosis RCC. The sensitivity of biopsy for small masses (≤3 cm) is lower than for large masses [4]. Sensitivity is limited by false-negative results, which are due to a failure to properly target a small mass or the presence of impossible-to-differentiate benign from malignant cells due to insufficient cells, morphological overlap or cellular heterogeneity. Non diagnostic biopsy is not necessary benign, as repeated biopsy reveals malignancy diagnosis in the majority[5]. There is no radiologic criteria consistent with oncocytoma because of a lack of sensitivity and specificity [6]. MR-scanning and CT-scanning are not feasible diagnostic methodologies for oncocytoma because of the possibility of overlapping results from oncocytoma and RCC [7].

Hypotheses: To investigate the ability of perfusion CT/US-scanning to facilitate recognition of different tumour sub-types in small renal masses less than 7 cm by non-invasive imagining technology.

Purpose: To recognize different subtype's renal tumor by non invasive scanning. Design: A descriptive study


Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Perfusion Scanning's for Kidney Tumors
Actual Study Start Date : February 2014
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Oben label
There is no intervention on this descriptive study



Primary Outcome Measures :
  1. To recognize different subtype's renal tumor by non invasive scanning. [ Time Frame: one year ]
    A perfusion scanning will be performed prior to nephrectomy and the curve of contrast perfusion to the tumor and normal kidney will be compared according to histological finding



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
the cohort will be selected from department of urology, Roskilde Hospital
Criteria

Inclusion Criteria:

  1. Patients suspecting to have renal tumors by CT/UL-scanning.
  2. Patients age between 35 and 75 years
  3. Normal renal function
  4. Can read and understand Danish
  5. Non - metastasis disease detected by scanning

Exclusion Criteria:

  1. Patients have a nephropathy (defined as e-GFR less than 50 ml/min/1.73cm³).
  2. Previous allergic reaction to intravenous contrast material.
  3. Untreated hyperthyroidism.
  4. Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971905


Locations
Denmark
Roskilde Hospital
Roskilde, Denmark, 4000
Sponsors and Collaborators
Nessn Azawi
Investigators
Principal Investigator: Nessn Azawi, M.D. Zealand University Hospital

Responsible Party: Nessn Azawi, consultant, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT01971905     History of Changes
Other Study ID Numbers: SJ-366
SJ-366 ( Other Grant/Funding Number: Regional Ethical Committee of Region Sjaelland )
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type