Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer
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ClinicalTrials.gov Identifier: NCT00821613 |
Recruitment Status :
Completed
First Posted : January 13, 2009
Last Update Posted : February 8, 2012
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Condition or disease |
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Breast Cancer |
Study Type : | Observational |
Actual Enrollment : | 1827 participants |
Observational Model: | Case-Only |
Official Title: | Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | February 2012 |
Actual Study Completion Date : | February 2012 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Gender: female
- Age: 18 years and older
- Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.
- Subject who have signed an informed consent form.
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 RI4.0.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821613
Israel | |
Hadassah Ein Kerem Medical Center | |
Jerusalem, Israel | |
Meir Medical Center | |
Kfar Saba, Israel | |
Rabin Medical Center | |
Petah Tikva, Israel | |
Sheba Medical Center | |
Ramat Gan, Israel | |
Kaplan Medical Center | |
Rehovot, Israel, 76100 | |
Assuta Ramat Hachayal Hospital | |
Tel Aviv, Israel |
Responsible Party: | Real Imaging Ltd. |
ClinicalTrials.gov Identifier: | NCT00821613 |
Other Study ID Numbers: |
Pr-118-8061 ver. 004 QMS number: 960-PRL-09011 |
First Posted: | January 13, 2009 Key Record Dates |
Last Update Posted: | February 8, 2012 |
Last Verified: | February 2012 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |