Breast CancerNCT00474604
Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants
A study testing diffusion-weighted magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging and magnetic resonance spectroscopic imaging in people with Breast Cancer, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also help doctors predict a patient's response to treatment. PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants. 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?
- diffusion-weighted magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging and magnetic resonance spectroscopic imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to 25 Apr 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who satisfy the following conditions are the only subjects who will be eligible for this study:
- Normal volunteers
- Subjects with known or suspected breast disease
- Subjects must have signed an approved consent form.
- Subjects must be ≥ 18 years old.
- The protocol nurse will check with the patient that there is no h/o kidney disease
Show all 13Show fewer
- Normal creatinine and estimated GFR* within 30 days under the following circumstances
- Had abnormal creatinine in the last 60 days
- Are over 60 years of age
- Has received chemotherapy within the past 30 days
- Has diabetes, HIV, renal disease or hx of renal cancer
- * GFR will be calculated using: http://www.kidney.org/professionals/kdoqi/gfr_calculator.cfm
- Patients with an eGFR>90ml/min reported within 30 days, and who have not had intervening chemotherapy or other treatment or condition that might deteriorate renal function, may receive any gadolinium agent.
Who cannot join
- Children will be excluded from this study.
- Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "MRI Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for each pre-menopausal subject.)
- Subjects found to have any constitutionally present non-MR compatible ferromagnetic materials will be excluded from this study.
- Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
- Subjects for whom an MRI is technically not feasible (e.g. breast volume, obesity)
- Subjects who have vascular access ports or other implanted devices rated as anything other than "Safe" or "Conditional 6"
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: MRI Evaluation of Breast Tumor Growth and Treatment Response
RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also help doctors predict a patient's response to treatment.
PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants.
Read the detailed description
OBJECTIVES:
- Develop and combine advanced, quantitative, multiparametric magnetic resonance imaging methods (i.e., dynamic contrast-enhanced MRI [DCE-MRI], diffusion-weighted MRI [DW-MRI], and magnetic resonance spectroscopy [MRS]) to characterize breast tumors in women with known or suspected breast cancer.
- Identify surrogate biomarkers that can guide diagnosis and treatment of breast cancer using these methods.
- Correlate biochemical information obtained from magnetic resonance analysis with clinical, radiologic, and pathologic findings in these patients.
- Establish an imaging data bank that includes information on DCE-MRI, DW-MRI, and MRS findings in these patients and in healthy participants.
OUTLINE: Quantitative, multi-parametric magnetic imaging methods will be employed for breast imaging for the following subjects:
- Group A: Healthy volunteers who undergo up to 3 breast MRIs over 6 weeks.
- Group B: Patients diagnosed with breast cancer who will: 1) undergo preoperative breast MRI followed by definitive surgery or 2) undergo MRI prior to initiating neoadjuvant chemotherapy, at 1-2 weeks after initiation of chemotherapy, and prior to definitive surgery.
Clinical information, including radiologic and pathologic data, on all patients is collected for inclusion in the imaging data bank.
After completion of the study, patients and healthy participants are followed periodically.
- Conditions
- Breast Cancer
- Being tested
- diffusion-weighted magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging, magnetic resonance spectroscopic imaging
- Keywords
- 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.
diffusion-weighted magnetic resonance imagingProcedure or surgery
A scan will be performed.
dynamic contrast-enhanced magnetic resonance imagingProcedure or surgery
A scan will be performed.
magnetic resonance spectroscopic imagingProcedure or surgery
A scan will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Participants without breast cancer | Active comparator | Not described Receives: Procedure: diffusion-weighted magnetic resonance imaging; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: magnetic resonance spectroscopic imaging |
| Participants with breast cancer | Experimental | Not described Receives: Procedure: diffusion-weighted magnetic resonance imaging; Procedure: dynamic contrast-enhanced magnetic resonance imaging; Procedure: magnetic resonance spectroscopic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of advanced, quantitative, multi-parametric magnetic resonance imaging (MRI) methods for characterizing breast tumors to develop potential surrogate imaging markers for diagnosis and prediction of treatment response
Quantitative, multi-parametric MRI imaging methods include Dynamic Contrast MRI, Diffusion Weighted MRI, and Magnetic Resonance Spectroscopy. Patients will include healthy female volunteers and women diagnosed with breast cancer. Time frames begin at study entry (healthy volunteers) , pre-surgical and pre- and post-chemotherapy (breast cancer patients)
Measured: on-study date and at 6 months, up to 4 years
Secondary outcomes (2)
Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings
Biochemical data from advanced MRIs are compared and contrasted with findings from patients' clinical, chemotherapeutic, and radiologic treatments for breast cancer.
Measured: at 6 months
Establishment of an imaging data bank
Results of advanced MRI imaging methods for subjects assessed after completion of all MRI procedures
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startMar 2006
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 209 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, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474604
- Sponsor's protocol ID
- VICC BRE 0588
- Other IDs
- P30CA068485, VU-VICC-BRE-0588, VU-VICC-IRB-051230
- Status last verified
- Nov 2023
- First submitted
- 16 May 2007
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Yankeelov TE, Lepage M, Chakravarthy A, Broome EE, Niermann KJ, Kelley MC, Meszoely I, Mayer IA, Herman CR, McManus K, Price RR, Gore JC. Integration of quantitative DCE-MRI and ADC mapping to monitor treatment response in human breast cancer: initial results. Magn Reson Imaging. 2007 Jan;25(1):1-13. doi: 10.1016/j.mri.2006.09.006. Epub 2006 Nov 21.
PubMed 17222711Li X, Abramson RG, Arlinghaus LR, Chakravarthy AB, Abramson V, Mayer I, Farley J, Delbeke D, Yankeelov TE. An algorithm for longitudinal registration of PET/CT images acquired during neoadjuvant chemotherapy in breast cancer: preliminary results. EJNMMI Res. 2012 Nov 16;2(1):62. doi: 10.1186/2191-219X-2-62.
PubMed 23157877
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Evaluation of Breast Tumor Growth and Treatment Response
- ClinicalTrials.gov ID
- NCT00474604
- Acronym / sponsor ID
- VICC BRE 0588
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2006 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 17 May 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.
RATIONALE: Diagnostic procedures, such as MRI, may help diagnose breast cancer. It may also help doctors predict a patient's response to treatment.
PURPOSE: This clinical trial is studying breast MRI in women with known or suspected breast cancer and in healthy participants.
Detailed description
OBJECTIVES:
- Develop and combine advanced, quantitative, multiparametric magnetic resonance imaging methods (i.e., dynamic contrast-enhanced MRI [DCE-MRI], diffusion-weighted MRI [DW-MRI], and magnetic resonance spectroscopy [MRS]) to characterize breast tumors in women with known or suspected breast cancer.
- Identify surrogate biomarkers that can guide diagnosis and treatment of breast cancer using these methods.
- Correlate biochemical information obtained from magnetic resonance analysis with clinical, radiologic, and pathologic findings in these patients.
- Establish an imaging data bank that includes information on DCE-MRI, DW-MRI, and MRS findings in these patients and in healthy participants.
OUTLINE: Quantitative, multi-parametric magnetic imaging methods will be employed for breast imaging for the following subjects:
- Group A: Healthy volunteers who undergo up to 3 breast MRIs over 6 weeks.
- Group B: Patients diagnosed with breast cancer who will: 1) undergo preoperative breast MRI followed by definitive surgery or 2) undergo MRI prior to initiating neoadjuvant chemotherapy, at 1-2 weeks after initiation of chemotherapy, and prior to definitive surgery.
Clinical information, including radiologic and pathologic data, on all patients is collected for inclusion in the imaging data bank.
After completion of the study, patients and healthy participants are followed periodically.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants without breast cancer | Active comparator | Procedure: diffusion-weighted magnetic resonance imaging, Procedure: dynamic contrast-enhanced magnetic resonance imaging, Procedure: magnetic resonance spectroscopic imaging |
| Participants with breast cancer | Experimental | Procedure: diffusion-weighted magnetic resonance imaging, Procedure: dynamic contrast-enhanced magnetic resonance imaging, Procedure: magnetic resonance spectroscopic imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Women who satisfy the following conditions are the only subjects who will be eligible for this study:
- Normal volunteers
- Subjects with known or suspected breast disease
- Subjects must have signed an approved consent form.
- Subjects must be ≥ 18 years old.
Key exclusion criteria (6 listed)
- Children will be excluded from this study.
- Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "MRI Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for each pre-menopausal subject.)
- Subjects found to have any constitutionally present non-MR compatible ferromagnetic materials will be excluded from this study.
- Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
- Subjects for whom an MRI is technically not feasible (e.g. breast volume, obesity)
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 |
|---|---|---|
| diffusion-weighted magnetic resonance imagingA scan will be performed. | Procedure or surgery | Participants with breast cancer, Participants without breast cancer |
| dynamic contrast-enhanced magnetic resonance imagingA scan will be performed. | Procedure or surgery | Participants with breast cancer, Participants without breast cancer |
| magnetic resonance spectroscopic imagingA scan will be performed. | Procedure or surgery | Participants with breast cancer, Participants without breast cancer |
Primary outcome
Feasibility of advanced, quantitative, multi-parametric magnetic resonance imaging (MRI) methods for characterizing breast tumors to develop potential surrogate imaging markers for diagnosis and prediction of treatment response
Time frame: on-study date and at 6 months, up to 4 years
Quantitative, multi-parametric MRI imaging methods include Dynamic Contrast MRI, Diffusion Weighted MRI, and Magnetic Resonance Spectroscopy. Patients will include healthy female volunteers and women diagnosed with breast cancer. Time frames begin at study entry (healthy volunteers) , pre-surgical and pre- and post-chemotherapy (breast cancer patients)
2 secondary outcomes
Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings
Time frame: at 6 months
Establishment of an imaging data bank
Time frame: at 6 months
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 27 Nov 2023.
- Results publication: PubMed 17222711Yankeelov TE, Lepage M, Chakravarthy A, Broome EE, Niermann KJ, Kelley MC, Meszoely I, Mayer IA, Herman CR, McManus K, Price RR, Gore JC. Integration of quantitative DCE-MRI and ADC mapping to monitor treatment response in human breast cancer: initial results. Magn Reson Imaging. 2007 Jan;25(1):1-13. doi: 10.1016/j.mri.2006.09.006. Epub 2006 Nov 21.
- Derived from this study: PubMed 23157877Li X, Abramson RG, Arlinghaus LR, Chakravarthy AB, Abramson V, Mayer I, Farley J, Delbeke D, Yankeelov TE. An algorithm for longitudinal registration of PET/CT images acquired during neoadjuvant chemotherapy in breast cancer: preliminary results. EJNMMI Res. 2012 Nov 16;2(1):62. doi: 10.1186/2191-219X-2-62.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink 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.
A. Bapsi Chakravarthy, MD principal investigator
Vanderbilt-Ingram Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion-weighted magnetic resonance imaging, dynamic contrast-enhanced magnetic resonance imaging and magnetic resonance spectroscopic imaging in people with Breast Cancer, run by Vanderbilt-Ingram 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 13 inclusion and 6 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 27 Nov 2023. 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?
Feasibility of advanced, quantitative, multi-parametric magnetic resonance imaging (MRI) methods for characterizing breast tumors to develop potential surrogate imaging markers for diagnosis and prediction of treatment response (time frame: on-study date and at 6 months, up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00474604, which also lists 2 linked publications.
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 27 Nov 2023.