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Trial registered on ANZCTR


Registration number
ACTRN12609000323224
Ethics application status
Approved
Date submitted
1/05/2009
Date registered
21/05/2009
Date last updated
5/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ultrasound scanning with contrast enhancement to assess disease activity in Crohn's disease
Scientific title
Contrast-enhanced ultrasound assessment of Crohn's disease activity
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's disease 4701 0
Condition category
Condition code
Oral and Gastrointestinal 5015 5015 0 0
Crohn's disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study - participants will receive up to two bolus intravenous injections of ultrasound contrast (perflutren lipid microsphere, each bolus approximately 0.75ml of contrast agent diluted to 5ml with normal saline) on each of the two visits. Contrast enhancement of the bowel wall will be observed for approximately 10 minutes post injection.
Intervention code [1] 4463 0
Not applicable
Comparator / control treatment
No concurrent controls. Patient will act as their own internal controls.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5855 0
Comparison of quantitative parameters derived from time-intensity curve of contrast enhancement of bowel wall with clinical and endoscopic parameters of disease activity
Timepoint [1] 5855 0
Outcomes will be measured once at enrolment and once on the second visit approximately 4-6 weeks post enrolment.
Secondary outcome [1] 241883 0
Comparison of bowel wall thickness with clinical and endoscopic parameters of disease activity
Timepoint [1] 241883 0
Outcomes will be measured once at enrolment and once on the second visit approximately 4-6 weeks post enrolment.

Eligibility
Key inclusion criteria
Patients with Crohn’s disease who are experiencing an exacerbation (Crohn’s disease activity index, CDAI >150) and who require a colonoscopy or flexible sigmoidoscopy
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant and lactating women, patients with abdominal surgery during the past 6 months, known right-to-left intracardiac shunts, unstable cardiac disease, pulmonary hypertension, severe chronic obstructive pulmonary disease, pulmonary vasculitis and hypersensitivity to ultrasound contrast agents.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4883 0
Commercial sector/Industry
Name [1] 4883 0
Lantheus Medical Imaging
Address [1] 4883 0
Bldg. 200-2
331 Treble Cove Rd,
N. Billerica, MA 01862
Country [1] 4883 0
United States of America
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
Wellington St,
Perth WA 6000
Country
Australia
Secondary sponsor category [1] 4415 0
None
Name [1] 4415 0
Address [1] 4415 0
Country [1] 4415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6948 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 6948 0
Wellington St,
Perth WA 6000
Ethics committee country [1] 6948 0
Australia
Date submitted for ethics approval [1] 6948 0
Approval date [1] 6948 0
17/12/2008
Ethics approval number [1] 6948 0
EC2008/199

Summary
Brief summary
The primary purpose of this study is to determine whether measurements obtained from an ultrasound scan of the bowel with the use of a contrast agent provides useful information on the disease activity of patients with Crohn's disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29553 0
Address 29553 0
Country 29553 0
Phone 29553 0
Fax 29553 0
Email 29553 0
Contact person for public queries
Name 12800 0
Dr Daniel Wong
Address 12800 0
Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
Wellington St,
Perth WA 6000
Country 12800 0
Australia
Phone 12800 0
+61 8 9224 2721
Fax 12800 0
Email 12800 0
daniel.wong@health.wa.gov.au
Contact person for scientific queries
Name 3728 0
Prof Richard Mendelson
Address 3728 0
Department of Diagnostic and Interventional Radiology
Royal Perth Hospital
Wellington St,
Perth WA 6000
Country 3728 0
Australia
Phone 3728 0
+61 8 9224 2129
Fax 3728 0
Email 3728 0
richard.mendelson@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary