Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer

NCT03080155 | Unknown

• 1 other identifier: 960-CLP-GER_Multimodality_GER1
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to assess the effectiveness of MIRA in classifying women with dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for correctly classifying women with breast cancer and to evaluate the safety of the device. In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle biopsy due to lesions detected by other imaging modalities.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• determining MIRA's PPV (positive predictive value)

  * The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using positive MRI (MRI BI-RADS \>= 3) as a reference test in cohort of women with negative (Mammography BI-RADS 1 or 2). * The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using the histological diagnosis as the reference test in ALL women participated in the study.

  24 months

Study Arms (1)

MIRA device imaging

EXPERIMENTAL

MIRA Device imaging for adjunctive detection of breast cancer

Device: MIRA device imaging

Interventions

MIRA device imaging DEVICE

MIRA Device imaging for adjunctive detection of breast cancer

Also known as: Real Imager 8

MIRA device imaging

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who are between 30 to 70 years of age and who are asymptomatic and scheduled to undergo routine breast cancer screening (MRI and/or mammography) OR
• Women who are between 30 to 79 years of age and scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or MRI) performed at the clinical site that participates in the study.

You may not qualify if:

• 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 \> 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 not 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.

Sponsors & Collaborators

• Real Imaging Ltd.: lead

Study Sites (1)

BrustZentrum

Göttingen, Germany

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Uwe Fischer, Prof.

  BrustZentrum, Göttingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Izhaky

CONTACT

+972-3-972-0602; David@realimaging.com

Study Design

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

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 15, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

DE (1)