Trial record 16 of 297 for:    Open Studies | "Kidney Neoplasms"

Perfusion Scanning's for Kidney Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Hospital Roskilde
Sponsor:
Information provided by (Responsible Party):
Nessn Azawi, University Hospital Roskilde
ClinicalTrials.gov Identifier:
NCT01971905
First received: October 19, 2013
Last updated: May 4, 2014
Last verified: May 2014
  Purpose

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
Kidney Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perfusion Scanning's for Kidney Tumors

Resource links provided by NLM:


Further study details as provided by University Hospital Roskilde:

Primary Outcome Measures:
  • To recognize different subtype's renal tumor by non invasive scanning. [ Time Frame: one year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Oben label
There is no intervention on this descriptive study

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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971905

Locations
Denmark
Roskilde Hospital Recruiting
Roskilde, Denmark, 4000
Contact: Nessn H. Azawi, M.D.    004526393034    nesa@regionsjaelland.dk   
Principal Investigator: Nessn Azawi, M.D.         
Roskilde Hospital Recruiting
Roskilde, Denmark, 4000
Contact: Nessn H. Azawi, MD    004526393034    nesa@regionsjaelland.dk   
Sponsors and Collaborators
Nessn Azawi
Investigators
Principal Investigator: Nessn Azawi, M.D. University Hospital Roskilde
  More Information

No publications provided

Responsible Party: Nessn Azawi, consultant, University Hospital Roskilde
ClinicalTrials.gov Identifier: NCT01971905     History of Changes
Other Study ID Numbers: SJ-366, SJ-366
Study First Received: October 19, 2013
Last Updated: May 4, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on July 22, 2014