Breast CancerNCT01090687
Role of 3D Tomography in Breast Cancer
An observational study of Breast Cancer, run by University of Rochester at 1 site in United States.
Trial summary
The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- computed tomography (CT scan)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam, and who meet the inclusion criteria, are eligible to participate.
Who may be able to join
- All women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam are eligible to participate, except for exclusions noted below.
- Able to provide informed consent.
Who cannot join
- Males
- Women less than 40 years old
- Pregnant women
- Lactating women
- Woman who have had bilateral mastectomies
- Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker
Show all 16Show fewer
- Women who are unable to tolerate study constraints, frail or unable to cooperate
- Women with large breasts that cannot be accommodated within the field of view of the CT system
- Women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to)
- Treatment for enlarged thymus gland as an infant
- Irradiation for benign breast conditions, including breast inflammation after giving birth
- Treatment for Hodgkin's disease
- Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram.
- Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to)
- Tuberculosis
- Severe scoliosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center, Highland Breast Imaging Center
Rochester, New York, 14623
About this study
The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.
- Conditions
- Breast Cancer
- Being tested
- computed tomography (CT scan)
- Keywords
- breast cancer, CT scans, mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomography (CT scan)Radiation
Also called CT scan
Subjects will undergo cone beam breast CT scan
computed tomography (CT scan)Device
Also called CT scan
Subjects will undergo cone beam breast CT scan
| Study group | Role | What they receive |
|---|---|---|
| Group I Microcalcifications | After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary findings based on microcalcifications will be recruited to have a breast CT scan. Receives: Radiation: computed tomography (CT scan) | |
| Group II Soft tissue findings | After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary soft tissue findings, with or without associated microcalcifications, will be recruited to have a breast CT scan. Receives: Device: computed tomography (CT scan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between mammography and breast CT on lesion detection
There are two specific aims of this pilot study. One specific aim is to determine if the lesions that are detected by mammography and referred for biopsy, are visible with breast CT. The other specific aim is to determine if there is a correlation between CT numbers and malignancy, in particular for soft tissue (solid masses) abnormalities and to determine if image processing techniques improve correlation between CT numbers and malignancy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Andrew Karellas, PhD, Principal investigator, University of Massachusetts, WorcesterStephen Glick, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090687
- Sponsor's protocol ID
- URMC-UMASS
- Other IDs
- 1R21CA134128-01A2
- Status last verified
- Jul 2013
- First submitted
- 22 Feb 2010
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tseng HW, Fu Z, Vedantham S. Simultaneous reduction of radiation dose and scatter-to-primary ratio using a truncated detector and advanced algorithms for dedicated cone-beam breast CT. Biomed Phys Eng Express. 2025 Mar 3;11(2):025047. doi: 10.1088/2057-1976/adb8f1.
PubMed 39983239
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of 3D Tomography in Breast Cancer
- ClinicalTrials.gov ID
- NCT01090687
- Acronym / sponsor ID
- URMC-UMASS
- Conditions
- Breast Cancer
- Keywords
- breast cancer, CT scans, mammography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 22 Mar 2010 (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.
The primary aim of this pilot study is to define the role of dedicated cone beam breast computed tomography in breast cancer imaging. This research is a prelude of a more comprehensive clinical trial that may follow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I Microcalcifications | – | Radiation: computed tomography (CT scan)After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary findings based on microcalcifications will be recruited to have a breast CT scan. |
| Group II Soft tissue findings | – | Device: computed tomography (CT scan)After classification as BI-RADS 4/5, approximately 75 to 100 subjects with primary soft tissue findings, with or without associated microcalcifications, will be recruited to have a breast CT scan. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam, and who meet the inclusion criteria, are eligible to participate.
Key inclusion criteria (2 listed)
- All women, age 40 or older, who are scheduled for biopsy after classification as BI-RADS 4/5 and have had a screening or diagnostic full-field digital mammography (FFDM) exam are eligible to participate, except for exclusions noted below.
- Able to provide informed consent.
Key exclusion criteria (16 listed)
- Males
- Women less than 40 years old
- Pregnant women
- Lactating women
- Woman who have had bilateral mastectomies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomography (CT scan)Also: CT scanSubjects will undergo cone beam breast CT scan | Radiation | Group I Microcalcifications |
| computed tomography (CT scan)Also: CT scanSubjects will undergo cone beam breast CT scan | Device | Group II Soft tissue findings |
Primary outcome
Correlation between mammography and breast CT on lesion detection
Time frame: 2 years
There are two specific aims of this pilot study. One specific aim is to determine if the lesions that are detected by mammography and referred for biopsy, are visible with breast CT. The other specific aim is to determine if there is a correlation between CT numbers and malignancy, in particular for soft tissue (solid masses) abnormalities and to determine if image processing techniques improve correlation between CT numbers and malignancy.
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 1 Aug 2013.
- Derived from this study: PubMed 39983239Tseng HW, Fu Z, Vedantham S. Simultaneous reduction of radiation dose and scatter-to-primary ratio using a truncated detector and advanced algorithms for dedicated cone-beam breast CT. Biomed Phys Eng Express. 2025 Mar 3;11(2):025047. doi: 10.1088/2057-1976/adb8f1.
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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.
Andrew Karellas, PhD principal investigator
University of Massachusetts, Worcester
Stephen Glick, PhD principal investigator
University of Massachusetts, Worcester
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 Breast Cancer, run by University of Rochester at 1 site in United States.
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 2 inclusion and 16 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 1 Aug 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 United States. 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.
What does the primary outcome measure?
Correlation between mammography and breast CT on lesion detection (time frame: 2 years). 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 NCT01090687, which also lists 1 linked publication.
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 1 Aug 2013.