Breast CancerNCT00656604
Evaluation of Patients With Breast Cancer Using DCE-MRI, MRS, and Proteomics
A study testing proteomic profiling, lumpectomy or mastectomy and dynamic contrast-enhanced magnetic resonance imaging in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center.
Trial summary
RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- proteomic profiling, lumpectomy or mastectomy and dynamic contrast-enhanced magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Jan 2008
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets 1 of the following criteria:
- Women with breast tumors planning to undergo surgical resection
- Healthy volunteers, including any constitutionally healthy female with no history of breast cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Not acutely ill
- No non-magnetic resonance-compatible ferromagnetic materials present in the body
PRIOR CONCURRENT THERAPY:
- Prior chemotherapy and/or radiotherapy allowed
About this study
Official title: Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics
RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment.
PURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics analysis to see how well they work in evaluating healthy women and women who are undergoing surgery for breast cancer.
Read the detailed description
OBJECTIVES:
- To correlate data obtained by DCE-MRI and MRS in healthy women and in women who are undergoing surgery for breast cancer with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology.
- To evaluate the impact of MRSI data on treatment planning for radiotherapy and/or surgery.
OUTLINE: Healthy participants undergo dynamic contrast-enhanced (DCE)-MRI and magnetic resonance spectroscopic (MRS) for longitudinal studies of breast imaging and spectroscopy.
Patients with breast cancers undergo DCE-MRI and MRS prior to initiation of treatment (i.e., surgery, chemotherapy, or radiotherapy). After treatment has begun, patients then undergo repeat imaging (not more than 1 per month) for follow-up assessments and longitudinal studies.
Breast tissue samples are collected from patients undergoing surgery. Samples are evaluated by histopathological and proteomic analysis for correlation with DCE-MRI and MRS findings.
The study interventions are discontinued after definitive surgery is performed.
PROJECTED ACCRUAL: A total of 10 healthy participants and 40 patients with breast cancer will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- proteomic profiling, lumpectomy or mastectomy, dynamic contrast-enhanced magnetic resonance imaging, histopathologic examination, magnetic resonance spectroscopy
- Keywords
- recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proteomic profilingGenetic
Also called proteomic analysis
at the time of each procedure.
lumpectomy or mastectomyProcedure or surgery
Also called None noted
removal of breast tumor or removal of the entire breast in which the tumor is located
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
Also called DCE-MRI
Prior to initiation of treatment
histopathologic examinationProcedure or surgery
Also called Not noted
After the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer
magnetic resonance spectroscopyProcedure or surgery
Also called MRS
Prior to initiation of treatment
| Study group | Role | What they receive |
|---|---|---|
| Women with breast cancer | Experimental | Patients undergo DCE-MRI and MRS prior to their breast cancer surgery. Receives: Genetic: proteomic profiling; Procedure: lumpectomy or mastectomy; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: histopathologic examination; Procedure: magnetic resonance spectroscopy |
| Healthy volunteers | No intervention | Women without breast cancer undergo DCE-MRI and MRS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of data obtained by DCE-MRI and magnetic resonance spectroscopy (MRS) with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology in women with breast cancer
Imaging and spectroscopic studies are performed before surgery. After surgery, this data will be compared and contrast with data obtained from conventional mammograms and the patient's tissue.
Measured: At time of breast surgery
Secondary outcomes (1)
Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer
Investigators will evaluate the effectiveness of spectroscopic data used to plan for the patient's post-imaging surgery and/or post-surgical radiotherapy.
Measured: After the last scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startNov 2003
- Primary completionOct 2005
- Study completionJan 2008
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, A Bapsi Chakravarthy, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- A. Bapsi Chakravarthy, MD, Study chair, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656604
- Sponsor's protocol ID
- VICC BRE 0358
- Other IDs
- P30CA068485, VU-VICC-BRE-0358, VU-VICC-IRB-030472
- Status last verified
- Mar 2013
- First submitted
- 10 Apr 2008
- Last updated
- 5 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Breast Cancer Using Dynamic Contrast-Enhanced Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, and Proteomics
- ClinicalTrials.gov ID
- NCT00656604
- Acronym / sponsor ID
- VICC BRE 0358
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 11 Apr 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.
RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging(DCE-MRI), magnetic resonance spectroscopy (MRS), and tissue proteomics, may help doctors find and diagnose breast cancer and plan the best treatment.
PURPOSE: This clinical trial is studying MRI and MRS with or without tissue proteomics analysis to see how well they work in evaluating healthy women and women who are undergoing surgery for breast cancer.
Detailed description
OBJECTIVES:
- To correlate data obtained by DCE-MRI and MRS in healthy women and in women who are undergoing surgery for breast cancer with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology.
- To evaluate the impact of MRSI data on treatment planning for radiotherapy and/or surgery.
OUTLINE: Healthy participants undergo dynamic contrast-enhanced (DCE)-MRI and magnetic resonance spectroscopic (MRS) for longitudinal studies of breast imaging and spectroscopy.
Patients with breast cancers undergo DCE-MRI and MRS prior to initiation of treatment (i.e., surgery, chemotherapy, or radiotherapy). After treatment has begun, patients then undergo repeat imaging (not more than 1 per month) for follow-up assessments and longitudinal studies.
Breast tissue samples are collected from patients undergoing surgery. Samples are evaluated by histopathological and proteomic analysis for correlation with DCE-MRI and MRS findings.
The study interventions are discontinued after definitive surgery is performed.
PROJECTED ACCRUAL: A total of 10 healthy participants and 40 patients with breast cancer will be accrued for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with breast cancer | Experimental | Genetic: proteomic profiling, Procedure: lumpectomy or mastectomy, Procedure: dynamic contrast-enhanced magnetic resonance imaging, Procedure: histopathologic examination, Procedure: magnetic resonance spectroscopyPatients undergo DCE-MRI and MRS prior to their breast cancer surgery. |
| Healthy volunteers | No intervention | –Women without breast cancer undergo DCE-MRI and MRS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| proteomic profilingAlso: proteomic analysisat the time of each procedure. | Genetic | Women with breast cancer |
| lumpectomy or mastectomyAlso: None notedremoval of breast tumor or removal of the entire breast in which the tumor is located | Procedure or surgery | Women with breast cancer |
| dynamic contrast-enhanced magnetic resonance imagingAlso: DCE-MRIPrior to initiation of treatment | Procedure or surgery | Women with breast cancer |
| histopathologic examinationAlso: Not notedAfter the breast tumor has been removed, examination of the tumor under a microscope to determine the type and grade of breast cancer | Procedure or surgery | Women with breast cancer |
| magnetic resonance spectroscopyAlso: MRSPrior to initiation of treatment | Procedure or surgery | Women with breast cancer |
Primary outcome
Correlation of data obtained by DCE-MRI and magnetic resonance spectroscopy (MRS) with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology in women with breast cancer
Time frame: At time of breast surgery
Imaging and spectroscopic studies are performed before surgery. After surgery, this data will be compared and contrast with data obtained from conventional mammograms and the patient's tissue.
1 secondary outcome
Evaluation of the impact of MRS data on treatment planning for radiotherapy and/or surgery in women with breast cancer
Time frame: After the last scan
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 Mar 2013.
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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.
A. Bapsi Chakravarthy, MD study chair
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing proteomic profiling, lumpectomy or mastectomy and dynamic contrast-enhanced magnetic resonance imaging in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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 of data obtained by DCE-MRI and magnetic resonance spectroscopy (MRS) with data obtained by conventional X-ray mammography, tissue proteomics, and histopathology in women with breast cancer (time frame: At time of breast surgery). 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 Mar 2013.