Breast CancersNCT00721903
Three Dimensional (3D) Ultrasound in Predicting Response to Breast Cancer Therapies
A study testing Ultrasound Scan and Mammography and Ultrasound in people with Breast Cancers, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans. 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
- Breast Cancers
- What is being tested?
- Ultrasound Scan and Mammography and Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2000to Sep 2014
- Phase
- Interventional
- 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
Who may be able to join
- Newly diagnosed breast cancer prior to receiving breast cancer therapy.
- Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.
Who cannot join
- Poorly controlled diabetes.
- Contralateral mastectomy prior to neoadjuvant chemotherapy.
- Not a surgical candidate.
- No previous axillary lymph node dissection.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: 3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies
The purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.
Read the detailed description
To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.
- Conditions
- Breast Cancers
- Being tested
- Ultrasound Scan, Mammography and Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ScanProcedure or surgery
10 female volunteers with normal breast who will be studied to refine imaging techniques and for comparison with patients. To the degree possible, the volunteer group will be age-matched to patients with symptoms, initially 30 to 70 years of age.
Mammography and UltrasoundProcedure or surgery
To determine how well from ultrasound scans, changes in malignant masses can be measured, and to whether the use of a dye visible by ultrasound will be useful in evaluating different therapies for breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Active comparator | Ultrasound scan Receives: Procedure: Ultrasound Scan |
| Cancer | Active comparator | 120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan Receives: Procedure: Mammography and Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
Self explanatory.
Measured: 2002-2014
Secondary outcomes (1)
Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.
Visually measure separation between two corresponding points in two ultrasound image volumes after registration to verify registration accuracy.
Measured: 2002-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startMar 2000
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancersStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Paul L. Carson Ph.D, University of Michigan
- Investigators
- Paul L. Carson, Ph.D., Principal investigator, University of MichiganPaul Carson, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721903
- Sponsor's protocol ID
- 2001-0124
- Other IDs
- UMCC 0005, P01CA087634
- Status last verified
- May 2016
- First submitted
- 23 Jul 2008
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Breast Ultrasound In Predicting Response to Breast Cancer Therapies
- ClinicalTrials.gov ID
- NCT00721903
- Acronym / sponsor ID
- 2001-0124
- Conditions
- Breast Cancers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Mar 2000
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Jul 2008 (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 purpose of this study is to determine how well changes can be determined in malignant masses from ultrasound scans.
Detailed description
To evaluate the proportions of correct diagnosis of response to breast Cancer therapies for localized breast cancer by ultrasound. To develop a model based on patient characteristics, physical exam, and radiologic studies which will predict the possibility that a patient has had a complete pathological response to chemotherapy neoadjuvant therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Active comparator | Procedure: Ultrasound ScanUltrasound scan |
| Cancer | Active comparator | Procedure: Mammography and Ultrasound120 women diagnosed by biopsy to have breast cancer will have an ultrasound scan |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly diagnosed breast cancer prior to receiving breast cancer therapy.
- Diagnosis of breast cancer must be confirmed by fine needle aspiration or core biopsy.
Key exclusion criteria (4 listed)
- Poorly controlled diabetes.
- Contralateral mastectomy prior to neoadjuvant chemotherapy.
- Not a surgical candidate.
- No previous axillary lymph node dissection.
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 |
|---|---|---|
| Ultrasound Scan10 female volunteers with normal breast who will be studied to refine imaging techniques and for comparison with patients. To the degree possible, the volunteer group will be age-matched to patients with symptoms, initially 30 to 70 years of age. | Procedure or surgery | Healthy Subjects |
| Mammography and UltrasoundTo determine how well from ultrasound scans, changes in malignant masses can be measured, and to whether the use of a dye visible by ultrasound will be useful in evaluating different therapies for breast cancer. | Procedure or surgery | Cancer |
Primary outcome
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images.
Time frame: 2002-2014
Self explanatory.
1 secondary outcome
Spatially register pre, intra and post treatment ultrasound image volumes of treated tumor.
Time frame: 2002-2014
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 5 May 2016.
Related trials for Breast Cancers
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Paul L. Carson, Ph.D. principal investigator
University of Michigan
Paul Carson, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Scan and Mammography and Ultrasound in people with Breast Cancers, run by University of Michigan 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 4 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 5 May 2016. 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?
Volume change on spatially registered (aligned) images tracks path. response better than volume change on unregistered images. (time frame: 2002-2014). 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 5 May 2016.