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Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants

Primary Purpose

Breast Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

diffusion-weighted magnetic resonance imaging

dynamic contrast-enhanced magnetic resonance imaging

magnetic resonance spectroscopic imaging

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

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
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.

Exclusion Criteria:

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"

Sites / Locations

Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Participants without breast cancer

Participants with breast cancer

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Establishment of an imaging data bank

Results of advanced MRI imaging methods for subjects assessed after completion of all MRI procedures

Full Information

NCT ID

NCT00474604

First Posted

May 16, 2007

Last Updated

December 11, 2022

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00474604

Brief Title

Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants

Official Title

MRI Evaluation of Breast Tumor Growth and Treatment Response

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 2006 (Actual)

Primary Completion Date

January 2025 (Anticipated)

Study Completion Date

December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

209 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants without breast cancer

Arm Type

Active Comparator

Arm Title

Participants with breast cancer

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

diffusion-weighted magnetic resonance imaging

Intervention Description

A scan will be performed.

Intervention Type

Procedure

Intervention Name(s)

dynamic contrast-enhanced magnetic resonance imaging

Intervention Description

A scan will be performed.

Intervention Type

Procedure

Intervention Name(s)

magnetic resonance spectroscopic imaging

Intervention Description

A scan will be performed.

Primary Outcome Measure Information:

Title

Description

Time Frame

on-study date and at 6 months, up to 4 years

Secondary Outcome Measure Information:

Title

Correlation of biochemical data obtained from magnetic resonance analysis with clinical, radiological, and pathological findings

Description

Biochemical data from advanced MRIs are compared and contrasted with findings from patients' clinical, chemotherapeutic, and radiologic treatments for breast cancer.

Time Frame

at 6 months

Title

Establishment of an imaging data bank

Description

Results of advanced MRI imaging methods for subjects assessed after completion of all MRI procedures

Time Frame

at 6 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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 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. Exclusion Criteria: 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"

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

A. Bapsi Chakravarthy, MD

Organizational Affiliation

Vanderbilt-Ingram Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-6838

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17222711

Citation

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.

Results Reference

result

PubMed Identifier

23157877

Citation

Li 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.

Results Reference

derived

Links:

URL

http://www.vicc.org/ct/

Description

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

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Breast MRI in Women With Known or Suspected Breast Cancer and in Healthy Participants

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