NCT01062178

Brief Summary

Patients with an incidentally discovered small renal masses (SRM) \< 4 cm in diameter are included. All patients will undergo biopsy for tissue diagnosis. Most patients will be followed by imaging. Study intervention includes low MI US to be performed following both bolus and infusion injection of Definity contrast. Presence and absence of vascularity, pattern of vascularity, and TIC values will be correlated with the final pathology to find features differentiating benign from malignant masses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
167

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Typical duration for phase_2

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

Study Start

First participant enrolled

October 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

January 22, 2010

Last Update Submit

March 7, 2016

Conditions

Renal Cell Carcinoma

Keywords

Small renal MassContrast Enhanced UltrasoundRenal Cell Carcinomanoninvasive diagnosis of RCC

Outcome Measures

Primary Outcomes (1)

  • biopsy

    12 to 18 months

Study Arms (1)

comparison to biopsy

EXPERIMENTAL

Comparing contrast enhanced US with biopsy result

Drug: Definity

Interventions

DefinityDRUG

Definity is the contrast agent which is going to be injected in a bolus and infusion forms during the ultrasound performance.

comparison to biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly diagnosed Renal mass \< 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

perflutren

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2010

First Posted

February 4, 2010

Study Start

October 1, 2009

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

March 8, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)