Breast CancerNCT00490503
Non-Invasive Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy Techniques (MRS) for Assessing Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2006to 18 Oct 2022
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Non-Invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-surgical Chemotherapy in Breast Cancer Patients
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.
Read the detailed description
In this study, MRI will be used to determine the effects of pre-surgical chemotherapy on breast cancer. MRS looks at the chemical components of tissue. MRS may be helpful in understanding how pre-surgical chemotherapy works.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1 teaspoon) will be drawn for routine tests. Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test.
If you are found to be eligible to take part in this study, you will have 3 MRI with MRS scans on both breast including the affected breast. The scans will be performed before chemotherapy, 21 days (plus or minus 3 days) after you start chemotherapy (Day 1 = your first day of chemotherapy), and at the end of the chemotherapy/before surgery. If you have never had an MRI scan before, you will be given the opportunity to watch a 10-minute video to prepare you for the procedure.
You will have specialized MRI scans: MRS, DCE, and DW. The DCE is a Dynamic Contrast Enhanced MRI. DCE-MRI is used to create a 3-D image of the breast tumor, so that the small blood vessels can be seen. The Diffusion-Weighted (DW) MRI may possibly be used to study the structure of tumor cells based on the movement of water molecules in tumor tissue.
For this, you will lie still on your stomach with your breasts positioned within the openings of the detector. A contrast drug, which helps the MRI scanner to show the breast lesion, will be injected through a needle in your vein. The procedure will take about 1 hour.
The tissues removed during the surgery will be collected as part of this study. Small pieces of tissues will be stained with special stains to give more information about the tumor (such as invasiveness, blood vessel supply, number of positive lymph nodes, tissue changes). Multiple sections of the tissues will be stained to make sure that all tissue areas of interest will be able to be compared with MRI/MRS images. The tissues then will be photographed and x-rayed.
You will be considered off-study 6 months after surgery. If you are unable to have surgery, you will be considered off-study 6 months after the last MRI with MRS.
This is an investigational study. The MRI with MRS scans are FDA approved and commercially available. The first and third scans will be part of routine patient care. The second scan is not part of routine care. Up to 28 participants will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Magnetic Resonance Imaging (MRI), Magnetic Resonance Spectroscopy (MRS)
- Keywords
- Breast Cancer, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, DCE-MRI, DW-MRI, MRS, MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Procedure or surgery
Also called MRI
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.
Magnetic Resonance Spectroscopy (MRS)Procedure or surgery
Also called MRS
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.
| Study group | Role | What they receive |
|---|---|---|
| MRI + MRS | Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy. Receives: Procedure: Magnetic Resonance Imaging (MRI); Procedure: Magnetic Resonance Spectroscopy (MRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2007 (estimated)
- Study start25 Oct 2006
- Primary completion18 Oct 2022
- Study completion18 Oct 2022
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.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary Whitman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490503
- Sponsor's protocol ID
- 2006-0501
- Other IDs
- P50CA116199
- Status last verified
- Oct 2022
- First submitted
- 20 Jun 2007
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-surgical Chemotherapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00490503
- Acronym / sponsor ID
- 2006-0501
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy, DCE-MRI, DW-MRI, MRS, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Oct 2006 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 22 Jun 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.
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.
Detailed description
In this study, MRI will be used to determine the effects of pre-surgical chemotherapy on breast cancer. MRS looks at the chemical components of tissue. MRS may be helpful in understanding how pre-surgical chemotherapy works.
Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1 teaspoon) will be drawn for routine tests. Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test.
If you are found to be eligible to take part in this study, you will have 3 MRI with MRS scans on both breast including the affected breast. The scans will be performed before chemotherapy, 21 days (plus or minus 3 days) after you start chemotherapy (Day 1 = your first day of chemotherapy), and at the end of the chemotherapy/before surgery. If you have never had an MRI scan before, you will be given the opportunity to watch a 10-minute video to prepare you for the procedure.
You will have specialized MRI scans: MRS, DCE, and DW. The DCE is a Dynamic Contrast Enhanced MRI. DCE-MRI is used to create a 3-D image of the breast tumor, so that the small blood vessels can be seen. The Diffusion-Weighted (DW) MRI may possibly be used to study the structure of tumor cells based on the movement of water molecules in tumor tissue.
For this, you will lie still on your stomach with your breasts positioned within the openings of the detector. A contrast drug, which helps the MRI scanner to show the breast lesion, will be injected through a needle in your vein. The procedure will take about 1 hour.
The tissues removed during the surgery will be collected as part of this study. Small pieces of tissues will be stained with special stains to give more information about the tumor (such as invasiveness, blood vessel supply, number of positive lymph nodes, tissue changes). Multiple sections of the tissues will be stained to make sure that all tissue areas of interest will be able to be compared with MRI/MRS images. The tissues then will be photographed and x-rayed.
You will be considered off-study 6 months after surgery. If you are unable to have surgery, you will be considered off-study 6 months after the last MRI with MRS.
This is an investigational study. The MRI with MRS scans are FDA approved and commercially available. The first and third scans will be part of routine patient care. The second scan is not part of routine care. Up to 28 participants will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI + MRS | – | Procedure: Magnetic Resonance Imaging (MRI), Procedure: Magnetic Resonance Spectroscopy (MRS)Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Also: MRI3 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. | Procedure or surgery | MRI + MRS |
| Magnetic Resonance Spectroscopy (MRS)Also: MRS3 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. | Procedure or surgery | MRI + MRS |
Primary outcome
Individual Analyses between Quantitative MR Measures + Pathologic Outcome Measures
Time frame: 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.
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.
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 31 Oct 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Gary Whitman, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by M.D. Anderson 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 10 inclusion and 8 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 31 Oct 2022. 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?
Individual Analyses between Quantitative MR Measures + Pathologic Outcome Measures (time frame: 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.). 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 31 Oct 2022.