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CompletedNCT01971905Updated Jan 24, 2018

Perfusion Scanning's for Kidney Tumors

An observational study in Kidney Cancer, sponsored by Nessn Azawi. Completed at 1 site in Denmark. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-24.

Sponsored by Nessn Azawi · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
56
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Kidney Cancer

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03

In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's enrollment of 56 is below the median of 218 across 216 observational studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Nessn Azawi is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

the cohort will be selected from department of urology, Roskilde Hospital

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
56 participants (actual)
Patient registry
No

Groups and cohorts

  • Oben label

    There is no intervention on this descriptive study

06

What researchers measure

Primary outcomes

  1. To recognize different subtype's renal tumor by non invasive scanning.

    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

    Time frame: one year

07

Study locations

1 site
  • Roskilde Hospital
    Roskilde, 4000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01971905
Lead sponsor
Nessn Azawi
Responsible party
Nessn Azawi (consultant, Zealand University Hospital) — Sponsor-investigator
First posted
Oct 29, 2013
Start date
Feb 2014
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Jan 24, 2018

Study contacts

Nessn Azawi, M.D.
principal investigator · Zealand University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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