Breast AbnormalitiesPhase 1NCT00630318
Testing New Method of Analyzing MR Images
A Phase 1 study testing MRI in people with Breast Abnormalities, run by Indiana University at 1 site in United States.
Trial summary
Preliminary imaging study to test for future use of this MRI-imaging for evaluating anti-angiogenesis treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Abnormalities
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2010
- Phase
- Phase 1
- 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
Who may be able to join
- Females
- Age 18 years or greater
- Undergoing breast MRI exam
Who cannot join
- Pregnancy
- Contraindication for MRI on standard screening checklist for clinically indicated examinations (i.e. metal devices/implants; history of claustrophobia)
- History/presence of any of the following to the breast: injury; breast implant; surgical or interventional procedure; clinically significant abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging Protocol Design for Anti-Angiogenesis Tracking With MRI
Preliminary imaging study to test for future use of this MRI-imaging for evaluating anti-angiogenesis treatment.
Read the detailed description
The purpose of this study is to develop and evaluate new MR imaging techniques and protocols for non-invasive monitoring of anti-angiogenesis treatment of breast cancer. This feasibility study is a preliminary imaging study to test this imaging protocol on subjects already undergoing MR for clinical purposes.
The specific objective of this research study is to develop and validate both MRI and functional MRI data acquisition methods, task paradigms, and post-processing techniques to ensure reliability of results.
The information derived from this research is intended to be applied to a future study of subjects undergoing experimental anti-angiogenesis drug therapy.
- Conditions
- Breast Abnormalities
- Being tested
- MRI
- Keywords
- MR scanning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
15-20 minutes MR imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide preliminary data for a larger study that this type of imaging can be used to monitor the effectiveness of anti-angiogenic therapy.
Measured: After analysis of images
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Unable to accrue enough subjects to analyze data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AbnormalitiesStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan E. Clare, MD, Ph.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630318
- Sponsor's protocol ID
- 0710-67
- Status last verified
- Jan 2017
- First submitted
- 28 Feb 2008
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Protocol Design for Anti-Angiogenesis Tracking With MRI
- ClinicalTrials.gov ID
- NCT00630318
- Acronym / sponsor ID
- 0710-67
- Conditions
- Breast Abnormalities
- Keywords
- MR scanning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to accrue enough subjects to analyze data.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Mar 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.
Preliminary imaging study to test for future use of this MRI-imaging for evaluating anti-angiogenesis treatment.
Detailed description
The purpose of this study is to develop and evaluate new MR imaging techniques and protocols for non-invasive monitoring of anti-angiogenesis treatment of breast cancer. This feasibility study is a preliminary imaging study to test this imaging protocol on subjects already undergoing MR for clinical purposes.
The specific objective of this research study is to develop and validate both MRI and functional MRI data acquisition methods, task paradigms, and post-processing techniques to ensure reliability of results.
The information derived from this research is intended to be applied to a future study of subjects undergoing experimental anti-angiogenesis drug therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females
- Age 18 years or greater
- Undergoing breast MRI exam
Key exclusion criteria (3 listed)
- Pregnancy
- Contraindication for MRI on standard screening checklist for clinically indicated examinations (i.e. metal devices/implants; history of claustrophobia)
- History/presence of any of the following to the breast: injury; breast implant; surgical or interventional procedure; clinically significant abnormality
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 |
|---|---|---|
| MRI15-20 minutes MR imaging | Device | – |
Primary outcome
To provide preliminary data for a larger study that this type of imaging can be used to monitor the effectiveness of anti-angiogenic therapy.
Time frame: After analysis of images
Results and safety
The study was stopped early (reason given: Unable to accrue enough subjects to analyze data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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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.
Susan E. Clare, MD, Ph.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRI in people with Breast Abnormalities, run by Indiana University 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 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: stopped early, as of the sponsor's last update on 12 Jan 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to accrue enough subjects to analyze data.). 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?
To provide preliminary data for a larger study that this type of imaging can be used to monitor the effectiveness of anti-angiogenic therapy. (time frame: After analysis of images). 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 12 Jan 2017.