NCT01971905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

3.9 years

First QC Date

October 19, 2013

Last Update Submit

January 22, 2018

Conditions

Kidney Cancer

Outcome Measures

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

    one year

Study Arms (1)

Oben label

There is no intervention on this descriptive study

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roskilde Hospital

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Nessn Azawi, M.D.

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
consultant

Study Record Dates

First Submitted

October 19, 2013

First Posted

October 29, 2013

Study Start

February 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

DK(1)