Breast LesionsNCT00599105
Angiogenesis in Early Breast Cancer for Prognosis Prediction
A study testing magnetic resonance imaging in people with Breast Lesions, run by University of California, Irvine at 1 site in United States.
Trial summary
This study will investigate the association of angiogenesis in breast cancer measured by magnetic resonance imaging and biomarkers with long-term prognosis of patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Lesions
- What is being tested?
- magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Jul 2010
- 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 18 to 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient with a breast mass highly suspicious for malignancy from clinical, mammographic or sonographic examination.
- The study has been explained to the patient when she is scheduled for surgery.
- Healthy normal volunteers for imaging protocol optimization.
Who cannot join
- Pregnancy
- Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,
- Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,
- Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,
- Patients with implanted prosthetic heart valves,
- Patients with pacemakers, neuro-stimulation devices,
- A breast mass with features of benign tumor
- The patients unwilling to participate in the study or fail to sign the consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Functional Onco-Imaging, University of California
Irvine, California, 92697
About this study
This study will investigate the association of angiogenesis in breast cancer measured by magnetic resonance imaging and biomarkers with long-term prognosis of patients.
- Conditions
- Breast Lesions
- Being tested
- magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingProcedure or surgery
MRI contrast agent, 0.1 mmol/kg
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate whether breast cancer with a higher angiogenesis activity is associated with a unfavorable outcome.
Measured: 5 years from completion of enrollment
Secondary outcomes (1)
To investigate whether angiogenesis of breast cancer is associated wit lymph node status
Measured: at completion of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startNov 2000
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast LesionsStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599105
- Sponsor's protocol ID
- UCI-HS-2000-1141
- Other IDs
- NIH-CA90437, CBCRP-9WB-0020
- Status last verified
- Nov 2010
- First submitted
- 10 Jan 2008
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiogenesis in Early Breast Cancer for Prognosis Prediction
- ClinicalTrials.gov ID
- NCT00599105
- Acronym / sponsor ID
- UCI-HS-2000-1141
- Conditions
- Breast Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Nov 2000
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 23 Jan 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.
This study will investigate the association of angiogenesis in breast cancer measured by magnetic resonance imaging and biomarkers with long-term prognosis of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with a breast mass highly suspicious for malignancy from clinical, mammographic or sonographic examination.
- The study has been explained to the patient when she is scheduled for surgery.
- Healthy normal volunteers for imaging protocol optimization.
Key exclusion criteria (8 listed)
- Pregnancy
- Patients with implanted surgical clips (hemostatic clips) or other ferromagnetic material,
- Patients engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or who may have imbedded metal fragments from military activities,
- Patients with metallic implants, because they may cause artifacts in diagnostic images due to magnetic field distortion,
- Patients with implanted prosthetic heart valves,
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 |
|---|---|---|
| magnetic resonance imagingMRI contrast agent, 0.1 mmol/kg | Procedure or surgery | – |
Primary outcome
To investigate whether breast cancer with a higher angiogenesis activity is associated with a unfavorable outcome.
Time frame: 5 years from completion of enrollment
1 secondary outcome
To investigate whether angiogenesis of breast cancer is associated wit lymph node status
Time frame: at completion of enrollment
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 19 Nov 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance imaging in people with Breast Lesions, run by University of California, Irvine 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 3 inclusion and 8 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 19 Nov 2010. 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?
To investigate whether breast cancer with a higher angiogenesis activity is associated with a unfavorable outcome. (time frame: 5 years from completion of enrollment). 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 19 Nov 2010.