- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03296683
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer
Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: David Izhaky
- Phone Number: +972-3-972-0602
- Email: David@realimaging.com
Study Locations
-
-
-
San Donato Milanese, Italy
- Recruiting
- Policlinico San Donato
-
Contact:
- Francesco Sardanelli, M.D.
- Phone Number: 39-02-52774468
- Email: f.sardanelli@grupposandonato.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
**Calibration Phase:
A.Subjects who are asymptomatic and scheduled to undergo routine screening mammography.
OR
B.Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care (mammography, ultrasound and/or MRI)
**Testing Phase:
A. Subjects scheduled to undergo routine screening mammography and at least one of the following :
- Subjects whose most recent (within 3 years) prior mammogram was interpreted as heterogeneously dense (ACR BI-RADS Breast Density 3) or extremely dense (ACR BI-RADS Breast Density 4).
- Subjects whose current 10-year IBIS breast cancer risk is 5% or higher.
EXCLUSION CRITERIA, valid for both calibration and testing phases:
- Male by birth.
- Individual is less than 24 years old.
- Contraindication to bilateral mammography or MRI.
- Subjects who are unable to read, understand and execute the informed consent procedure.
- Subjects who have had mammography, ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
- Subjects who have significant existing breast trauma.
- Subjects who have undergone lumpectomy/mastectomy.
- Subjects who have undergone breast reduction or breast augmentation.
- Subjects who have undergone any other type of breast surgery.
- Subjects who have large breast scar / Breast deformation.
- Subjects who have undergone a breast needle biopsy within the 6 month period prior to their intended enrollment into the study.
- Subjects who have a temperature > 100° F (37.8C) degrees on the day of the MIRA imaging.
- Subjects who are pregnant or lactating.
- Subjects who have had placement of an internal breast marker.
- Subjects with known Raynaud's Disease.
- Subjects that are claustrophobic or have physical limitations that do allow them to sit in the system chair for the required imaging session.
- Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices.
- Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy).
- Subjects affected with epilepsy.
- Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MIRA device imaging
MIRA Device imaging for adjunctive detection of breast cancer
|
MIRA Device imaging for adjunctive detection of breast cancer
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increase in incremental cancer detection rate
Time Frame: 24 months
|
Statistically significant increase of 30% or more in incremental cancer detection rate
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Francesco Sardanelli, M.D, Policlinico San Donato
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 960-CLP-ITL_RI8 _ITS1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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