Small Breast LesionsNCT01004666
Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions
An observational study of Small Breast Lesions and Dense Breast Tissue, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of CZT detectors,for assessment of breast pathology specifically in… Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Small Breast Lesions, Dense Breast Tissue, Discrepancy With Clinical Examination
- How many people
- 500 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2009to Oct 2015
- 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 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A wide COHORT from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Women with equivocal findings on Mammography, US and/or MRI. Women with discrepancy between clinical examination and conventional breast imaging. Women with dense breast. Women with genetic and/or family history high risk for Breast Cancer
Who may be able to join
- Age over 25.
- Equivocal breast lesions.
- Dense breast tissue.
- High-risk for breast cancer
Who cannot join
- Age under 25.
- Pregnancy.
- Patients unable to understand and sign an informed consent
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Einat Even-Sapir, MD, PhD, 972-3-6974444 ext. 3536, evensap@tasmc.health.gov.il
Ayelet Kurzband, BA, 972-3-6974444 ext. 3536, ayeletk@tasmc.health.gov.il
About this study
Official title: Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions.
Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of CZT detectors,for assessment of breast pathology specifically in women where current imaging techniques, mainly mammography are suboptimal. These cohort are patients with dense breast tissue and patients who are at high risk for breast cancer by a combination of other metrics, including family history and genetic testing. BRCA (breast cancer susceptibility gene), is particularly a relevant health problem among Ashkenazi Jews in Israel.
Read the detailed description
Recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in Mayo Clinic, Rochester, USA. Molecular Breast Imaging (MBI), which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions > 5 mm in diameter and 69% for tumors smaller than 5mm.
In Israel , genetic high- risk for breast cancer is highly relevant. We will offer the new imaging technology, to a wide patients population/group from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Therefore this stage will include:
- Women with equivocal findings on Mammography, US and/or MRI
- Women with discrepancy between CBE(clinical breast examination)and breast imaging
- Women with dense breast
- Women in high risk for Breast Cancer
Before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc.
The images will be correlated with other imaging tests including mammography, US and MRI. We will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams.
This phase will include 500 women.
- Conditions
- Small Breast Lesions, Dense Breast Tissue, Discrepancy With Clinical Examination, Equivocal Mammographic, Sonographic or MRI Lesion
- Keywords
- Breast cancer, Scintimammography, CZT, High-risk
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with equivocal findings on Mammography, US and/or MRI | Women with equivocal findings on Mammography, US and/or MRI | |
| Discrepancy between clinical examination and imaging | Women with discrepancy between clinical examination and breast imaging | |
| Women with dense breast | Women with dense breast | |
| Women in high risk for Breast Cancer | Women in high risk for Breast Cancer. Including patients with genetic high risk and/or strong family history. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of unexpected malignant lesions. Ruling out malignant lesions in case of equivocal lesions identified by clinical examination, mammography, US and/or MRI.
Measured: 6 mounth post scintigraphy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2014 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Small Breast LesionsStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Einat Even-Sapir, MD, PhD, Principal investigator, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004666
- Sponsor's protocol ID
- TASMC-09-EE-0192-CTIL
- Status last verified
- Jan 2013
- First submitted
- 29 Oct 2009
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hruska CB, Phillips SW, Whaley DH, Rhodes DJ, O'Connor MK. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. AJR Am J Roentgenol. 2008 Dec;191(6):1805-15. doi: 10.2214/AJR.07.3693.
PubMed 19020253Hruska CB, Boughey JC, Phillips SW, Rhodes DJ, Wahner-Roedler DL, Whaley DH, Degnim AC, O'Connor MK. Scientific Impact Recognition Award: Molecular breast imaging: a review of the Mayo Clinic experience. Am J Surg. 2008 Oct;196(4):470-6. doi: 10.1016/j.amjsurg.2008.06.005. Epub 2008 Aug 23.
PubMed 18723155Hruska CB, O'Connor MK. Quantification of lesion size, depth, and uptake using a dual-head molecular breast imaging system. Med Phys. 2008 Apr;35(4):1365-76. doi: 10.1118/1.2885371.
PubMed 18491531
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions.
- ClinicalTrials.gov ID
- NCT01004666
- Acronym / sponsor ID
- TASMC-09-EE-0192-CTIL
- Conditions
- Small Breast Lesions, Dense Breast Tissue, Discrepancy With Clinical Examination, Equivocal Mammographic, Sonographic or MRI Lesion
- Keywords
- Breast cancer, Scintimammography, CZT, High-risk
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Oct 2009
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 30 Oct 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.
Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of CZT detectors,for assessment of breast pathology specifically in women where current imaging techniques, mainly mammography are suboptimal. These cohort are patients with dense breast tissue and patients who are at high risk for breast cancer by a combination of other metrics, including family history and genetic testing. BRCA (breast cancer susceptibility gene), is particularly a relevant health problem among Ashkenazi Jews in Israel.
Detailed description
Recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in Mayo Clinic, Rochester, USA. Molecular Breast Imaging (MBI), which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions > 5 mm in diameter and 69% for tumors smaller than 5mm.
In Israel , genetic high- risk for breast cancer is highly relevant. We will offer the new imaging technology, to a wide patients population/group from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Therefore this stage will include:
- Women with equivocal findings on Mammography, US and/or MRI
- Women with discrepancy between CBE(clinical breast examination)and breast imaging
- Women with dense breast
- Women in high risk for Breast Cancer
Before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc.
The images will be correlated with other imaging tests including mammography, US and MRI. We will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams.
This phase will include 500 women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Women with equivocal findings on Mammography, US and/or MRI | – | –Women with equivocal findings on Mammography, US and/or MRI |
| Discrepancy between clinical examination and imaging | – | –Women with discrepancy between clinical examination and breast imaging |
| Women with dense breast | – | –Women with dense breast |
| Women in high risk for Breast Cancer | – | –Women in high risk for Breast Cancer. Including patients with genetic high risk and/or strong family history. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A wide COHORT from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Women with equivocal findings on Mammography, US and/or MRI. Women with discrepancy between clinical examination and conventional breast imaging. Women with dense breast. Women with genetic and/or family history high risk for Breast Cancer
Key inclusion criteria (4 listed)
- Age over 25.
- Equivocal breast lesions.
- Dense breast tissue.
- High-risk for breast cancer
Key exclusion criteria (3 listed)
- Age under 25.
- Pregnancy.
- Patients unable to understand and sign an informed consent
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
Detection of unexpected malignant lesions. Ruling out malignant lesions in case of equivocal lesions identified by clinical examination, mammography, US and/or MRI.
Time frame: 6 mounth post scintigraphy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
- Background: PubMed 19020253Hruska CB, Phillips SW, Whaley DH, Rhodes DJ, O'Connor MK. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. AJR Am J Roentgenol. 2008 Dec;191(6):1805-15. doi: 10.2214/AJR.07.3693.
- Background: PubMed 18723155Hruska CB, Boughey JC, Phillips SW, Rhodes DJ, Wahner-Roedler DL, Whaley DH, Degnim AC, O'Connor MK. Scientific Impact Recognition Award: Molecular breast imaging: a review of the Mayo Clinic experience. Am J Surg. 2008 Oct;196(4):470-6. doi: 10.1016/j.amjsurg.2008.06.005. Epub 2008 Aug 23.
- Background: PubMed 18491531Hruska CB, O'Connor MK. Quantification of lesion size, depth, and uptake using a dual-head molecular breast imaging system. Med Phys. 2008 Apr;35(4):1365-76. doi: 10.1118/1.2885371.
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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.
Einat Even-Sapir, MD, PhD principal investigator
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Breast Lesions and Dense Breast Tissue, run by Tel-Aviv Sourasky Medical Center at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Einat Even-sapir, PhD, MD (972-3-6974444 ext. 3536, evensap@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of unexpected malignant lesions. Ruling out malignant lesions in case of equivocal lesions identified by clinical examination, mammography, US and/or MRI. (time frame: 6 mounth post scintigraphy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01004666, which also lists 3 linked publications.
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 4 Jan 2013.