NCT00750464

Brief Summary

Collection of thermal "images" of women with breast tumors in varying degrees of severity in order to evaluate and improve Real Imaging's device ("RI3.0") capabilities , which will assist in early detection of breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
575

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

First QC Date

September 9, 2008

Last Update Submit

October 12, 2009

Conditions

Breast Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy

You may qualify if:

  • Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy.

You may not qualify if:

  • Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, prior to being "imaged" by RI3.0.
  • Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
  • Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
  • Subjects who have undergone a mastectomy.
  • Subjects who have a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
  • Subjects with prior breast reduction surgery or breast augmentation surgery.
  • Subjects who have a fever on the day of their biopsy.
  • Subjects who are pregnant.
  • Subjects who are breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Carmel Medical Center - Lin

Haifa, Israel

Location

Hadassah Medical Organization

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Miri Sklair-Levy, MD

    Hadassah Medical Organization, Jerusalem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

November 1, 2008

Study Completion

August 1, 2009

Last Updated

October 14, 2009

Record last verified: 2009-10

Locations

IL(4)