Breast CancerNCT00821613
Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer
An observational study of Breast Cancer, run by Real Imaging Ltd. at 6 sites in Israel.
Trial summary
Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 1,827 participants
- Where
- 6 sitesIsrael
- Study dates
- Sep 2009to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- Subjects who have a fever on the day of their biopsy.
- Subjects who are pregnant.
- Subjects who are breast-feeding.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Israel6 sites
Hadassah Ein Kerem Medical Center
Jerusalem
Meir Medical Center
Kfar Saba
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Kaplan Medical Center
Rehovot, 76100
Assuta Ramat Hachayal Hospital
Tel Aviv
About this study
Official title: Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer
Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 1,827 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Imaging Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821613
- Sponsor's protocol ID
- Pr-118-8061 ver. 004
- Other IDs
- QMS number: 960-PRL-09011
- Status last verified
- Feb 2012
- First submitted
- 12 Jan 2009
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer
- ClinicalTrials.gov ID
- NCT00821613
- Acronym / sponsor ID
- Pr-118-8061 ver. 004
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,827 participants (actual)
- Lead sponsor
- Real Imaging Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer.
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Real Imaging Ltd. at 6 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.