Breast CancerNCT00502814
3-Dimensional Form and Soft Tissue Biomechanics of the Breast
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to characterize the 3-dimensional form and mechanical properties of the breast. Researchers want to do this in order to develop new high technology tools for improving the diagnosis and treatment of breast cancer in women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 3-D Optical Surface Scan, Mechanical Testing and Cutaneous Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Oct 2011
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Breast Cancer.
Who may be able to join
- Female
- Greater than 18 years old.
- Presenting complaint requires breast physical examination.
- Free of connective tissue disorders and cutaneous malignancy on the breast.
- Free of medical conditions that contraindicate MRI or CT scanning.
- Willing to participate in the study and able to complete informed consent.
Who cannot join
- 1) Patients who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical research study is to characterize the 3-dimensional form and mechanical properties of the breast. Researchers want to do this in order to develop new high technology tools for improving the diagnosis and treatment of breast cancer in women.
Read the detailed description
Patients who participate in the study will have general physical and demographic information recorded. Height, weight, age, race, menstrual status, and bra size will all be recorded. Patients will have a breast physical exam. Researchers will then perform several painless tests and imaging studies to evaluate the mechanical properties of the skin and the shape and tissue composition of the breasts.
Patients in this study will go through a series of evaluations as listed below.
- 3-D Optical Surface Scan (estimated time required: 5 minutes) The camera system with a safe scanning laser will be used to take 3-D digitized images of the breasts and chest. Multiple images may be necessary to get a complete rendering of both breasts. Each image requires less than 0.6 seconds to take. This process is similar to the routine photography currently performed on most patients.
- Mechanical testing (estimated time required: 1 hour) A small device will be applied with the surface of the skin at several locations on the breasts. A mild suction will be applied for several seconds for each measurement. This will measure how the skin tends to stretch. The instruments used are very sensitive and provide the information needed with very small, painless amounts of movement in the skin. In addition to evaluating characteristics of the breast skin, one additional measure will be taken on the skin at the front of the forearm area to help understand your general skin qualities.
- Skin Ultrasound (estimated time required: 15 minutes) Patients will have a cutaneous ultrasound using the 20 MHz machine and the skin thickness will be recorded in each of the domains. A trained technician will complete this exam. In addition to evaluating characteristics of the breast skin, one additional measure will be taken on the skin at the front of the forearm area to help understand your general skin qualities.
- Breast MRI and/or CT (estimated time required: 1 hour) Some patients will be scheduled for imaging of the breasts and chest using MRI and/or CT. These images will be taken free-of-charge as they are not required for standard of care.
Participation will be over once the evaluations are complete.
This is an investigational study. A total of 200 patients will take part in this study. All will be enrolled at M. D. Anderson. After the first 50 patients are enrolled, the results will be studied to see if the study will continue. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- 3-D Optical Surface Scan, Mechanical Testing, Cutaneous Ultrasound, Breast MRI and/or CT
- Keywords
- Breast Cancer, 3-D Optical Surface Scan, Soft Tissue Biomechanics, Mechanical Testing, Skin Ultrasound, Magnetic Resonance Imaging, CT Scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-D Optical Surface ScanProcedure or surgery
3-D digitized images of the breasts and chest will be taken over a period of five minutes.
Mechanical TestingProcedure or surgery
A small device with a mild suction will be used to measure how the skin tends to stretch.
Cutaneous UltrasoundProcedure or surgery
Cutaneous ultrasound using a 20 MHz machine and the skin thickness will be recorded.
Breast MRI and/or CTProcedure or surgery
Imaging of the breasts and chest using an MRI and/or CT scan over about one hour.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with Breast Cancer. Receives: Procedure: 3-D Optical Surface Scan; Procedure: Mechanical Testing; Procedure: Cutaneous Ultrasound; Procedure: Breast MRI and/or CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Individual 3-dimensional Form and Mechanical Properties of Patient's Breast
Measured: Patient participation is approximately 1 Day for breast scans and mechanical measure, as well as ultrasound and Breast MRI/CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startJan 2003
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Sample size too small for data analysis.
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.
- More trials run by M.D. Anderson Cancer 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Beahm, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502814
- Sponsor's protocol ID
- ID01-305
- Status last verified
- Feb 2012
- First submitted
- 16 Jul 2007
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3-Dimensional Form and Soft Tissue Biomechanics of the Breast
- ClinicalTrials.gov ID
- NCT00502814
- Acronym / sponsor ID
- ID01-305
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, 3-D Optical Surface Scan, Soft Tissue Biomechanics, Mechanical Testing, Skin Ultrasound, Magnetic Resonance Imaging, CT Scan
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sample size too small for data analysis.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 18 Jul 2007 (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 goal of this clinical research study is to characterize the 3-dimensional form and mechanical properties of the breast. Researchers want to do this in order to develop new high technology tools for improving the diagnosis and treatment of breast cancer in women.
Detailed description
Patients who participate in the study will have general physical and demographic information recorded. Height, weight, age, race, menstrual status, and bra size will all be recorded. Patients will have a breast physical exam. Researchers will then perform several painless tests and imaging studies to evaluate the mechanical properties of the skin and the shape and tissue composition of the breasts.
Patients in this study will go through a series of evaluations as listed below.
- 3-D Optical Surface Scan (estimated time required: 5 minutes) The camera system with a safe scanning laser will be used to take 3-D digitized images of the breasts and chest. Multiple images may be necessary to get a complete rendering of both breasts. Each image requires less than 0.6 seconds to take. This process is similar to the routine photography currently performed on most patients.
- Mechanical testing (estimated time required: 1 hour) A small device will be applied with the surface of the skin at several locations on the breasts. A mild suction will be applied for several seconds for each measurement. This will measure how the skin tends to stretch. The instruments used are very sensitive and provide the information needed with very small, painless amounts of movement in the skin. In addition to evaluating characteristics of the breast skin, one additional measure will be taken on the skin at the front of the forearm area to help understand your general skin qualities.
- Skin Ultrasound (estimated time required: 15 minutes) Patients will have a cutaneous ultrasound using the 20 MHz machine and the skin thickness will be recorded in each of the domains. A trained technician will complete this exam. In addition to evaluating characteristics of the breast skin, one additional measure will be taken on the skin at the front of the forearm area to help understand your general skin qualities.
- Breast MRI and/or CT (estimated time required: 1 hour) Some patients will be scheduled for imaging of the breasts and chest using MRI and/or CT. These images will be taken free-of-charge as they are not required for standard of care.
Participation will be over once the evaluations are complete.
This is an investigational study. A total of 200 patients will take part in this study. All will be enrolled at M. D. Anderson. After the first 50 patients are enrolled, the results will be studied to see if the study will continue. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: 3-D Optical Surface Scan, Procedure: Mechanical Testing, Procedure: Cutaneous Ultrasound, Procedure: Breast MRI and/or CTPatients with Breast Cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Breast Cancer.
Key inclusion criteria (6 listed)
- Female
- Greater than 18 years old.
- Presenting complaint requires breast physical examination.
- Free of connective tissue disorders and cutaneous malignancy on the breast.
- Free of medical conditions that contraindicate MRI or CT scanning.
Key exclusion criteria (1 listed)
- 1) Patients who do not meet inclusion criteria.
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 |
|---|---|---|
| 3-D Optical Surface Scan3-D digitized images of the breasts and chest will be taken over a period of five minutes. | Procedure or surgery | 1 |
| Mechanical TestingA small device with a mild suction will be used to measure how the skin tends to stretch. | Procedure or surgery | 1 |
| Cutaneous UltrasoundCutaneous ultrasound using a 20 MHz machine and the skin thickness will be recorded. | Procedure or surgery | 1 |
| Breast MRI and/or CTImaging of the breasts and chest using an MRI and/or CT scan over about one hour. | Procedure or surgery | 1 |
Primary outcome
Individual 3-dimensional Form and Mechanical Properties of Patient's Breast
Time frame: Patient participation is approximately 1 Day for breast scans and mechanical measure, as well as ultrasound and Breast MRI/CT
Results and safety
The study was stopped early (reason given: Sample size too small for data analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Elisabeth Beahm, MD principal investigator
M.D. Anderson Cancer Center
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 M.D. Anderson Cancer Center 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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 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 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 was stopped early (reason given: Sample size too small for data analysis.). Results are not available in the source record.
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?
Individual 3-dimensional Form and Mechanical Properties of Patient's Breast (time frame: Patient participation is approximately 1 Day for breast scans and mechanical measure, as well as ultrasound and Breast MRI/CT). It is what the study was designed to measure, not a finding.
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 22 Feb 2012.