Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
Non-Invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-surgical Chemotherapy in Breast Cancer Patients
2 other identifiers
observational
20
1 country
1
Brief Summary
The goal of this clinical research study is to learn if magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS) can show the effects of pre-surgical chemotherapy in breast cancer patients who are eligible to receive preoperative chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2006
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2006
CompletedFirst Submitted
Initial submission to the registry
June 20, 2007
CompletedFirst Posted
Study publicly available on registry
June 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2022
CompletedOctober 31, 2022
October 1, 2022
16 years
June 20, 2007
October 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Individual Analyses between Quantitative MR Measures + Pathologic Outcome Measures
Quantitative measures of tissue function obtained non-invasively by dynamic contrast enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and proton MR spectroscopy (1H MRS) techniques to assess effects of pre-surgical chemotherapy in breast cancer patients eligible for preoperative chemotherapy.
Before chemotherapy, 21 ± 3 days after the initiation of chemotherapy (day 1 = first day of chemotherapy), and at end of chemotherapy and prior to any surgery.
Study Arms (1)
MRI + MRS
Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.
Interventions
3 Scans performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.
3 MRI Scans with MRS performed before chemotherapy, 21 days (plus or minus 3 days) after start chemotherapy (Day 1 = your first day of chemotherapy), and at end of chemotherapy/before surgery.
Eligibility Criteria
Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.
You may qualify if:
- Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.
- Patients must have a histological diagnosis of invasive breast cancer.
- Patients whose extent of disease is determined by physical examination and conventional imaging (mammography and sonography).
- Patients should have not received any previous chemotherapy for their newly diagnosed Stage II A-B or III A-C breast cancer.
- Patients must be age 18 or older.
- ECOG performance status 0-2.
- Patients with history of prior malignancies must be disease-free for at least 5 years prior of study entry.
- Normal hematological function: WBC \> 3000/ul, absolute neutrophil count \> 1500/ul, platelets \> 100,000/ul, and Hgb \> 10 gms (transfusion to achieve Hgb \> 10 gms is acceptable).
- Serum total bilirubin \< 1.5 mg/dl and SGPT \< 1.5 X normal.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol.
You may not qualify if:
- Patients who received previous chemotherapy for the newly diagnosed breast cancer.
- Patients with no evidence of primary breast lesion (e.g., T0, Tx).
- Patients who are unwilling to come back for regular assessments of response.
- Patients with claustrophobia or obesity (exceeding the equipment weight limits).
- Pregnant women, lactating women or sexually active women of childbearing potential who are not practicing adequate contraception.
- Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmias.
- Patients with pacemakers or other metallic inserts that are not compatible with 3-T MR scanners.
- Patients with bilateral breast disease, and recurrent newly diagnosed breast cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Biospecimen
The tissues removed during surgery (mastectomy) will be collected as part of this study.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Whitman, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2007
First Posted
June 22, 2007
Study Start
October 25, 2006
Primary Completion
October 18, 2022
Study Completion
October 18, 2022
Last Updated
October 31, 2022
Record last verified: 2022-10