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CompletedNCT00750464Updated Oct 14, 2009

Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer

An observational study in Breast Cancer, sponsored by Real Imaging Ltd.. Completed at 4 sites in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-14.

Sponsored by Real Imaging Ltd. · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
575
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 575 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Real Imaging Ltd. is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
575 participants (actual)
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Study locations

4 sites
  • Carmel Medical Center - Lin
    Haifa, Israel
  • Hadassah Medical Organization
    Jerusalem, Israel
  • Meir Medical Center
    Kfar Saba, Israel
  • Rabin Medical Center
    Petah Tikva, Israel
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00750464
Lead sponsor
Real Imaging Ltd.
First posted
Sep 10, 2008
Start date
Nov 2008
Completion
Aug 2009
Last update
Oct 14, 2009

Study contacts

Miri Sklair-Levy, MD
principal investigator · Hadassah Medical Organization, Jerusalem

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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