NCT01391039

Brief Summary

This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

June 15, 2011

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

3.8 years

First QC Date

June 15, 2011

Last Update Submit

November 26, 2015

Conditions

Ductal Carcinoma In-situ

Keywords

Ductal Carcinoma In-situContrast UltrasoundMicroinvasionElastography

Outcome Measures

Primary Outcomes (1)

  • Evidence of the presence of angiogenic tumour vasculature in patients diagnosed with DCIS utilizing contrast enhanced ultrasound.

    The participant will be followed up till the results of the biopsy, an expected average of 3 months.

Secondary Outcomes (1)

  • Measurement of transient shear wave elastography .

    The participant will be followed up till the results of the biopsy, an expected average of 3 months.

Study Arms (1)

Contrast perfusion and elastography arm

EXPERIMENTAL

Intravenous injection of microbubble contrast agent and elastography

Drug: Perflutren lipid microsphere

Interventions

Perflutren lipid microsphereDRUG

Intravenous injection of 10 microL/kg once prior to ultrasound examination

Also known as: Definity
Contrast perfusion and elastography arm

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A woman with imaging signs suggesting a diagnosis of DCIS who is scheduled for ultrasound and a biopsy is eligible for the study.
  • At least 18 years of age

You may not qualify if:

  • Pregnant or possibly pregnant or breast feeding
  • Unable to provide informed consent
  • Drug or multiple allergies
  • Known cardiac shunts
  • Known cardiac or chronic pulmonary disease
  • Hypersensitivity to perflutren

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Interventions

perflutren

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Roberta A Jong, FRCPC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2011

First Posted

July 11, 2011

Study Start

September 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 30, 2015

Record last verified: 2015-11

Locations

CA(1)