Breast CancerNCT00312637
Using Magnetic Resonance Spectroscopy With MRI to Non-invasively Determine Breast Cancer Extent of Disease
A study testing Magnetic Resonance Spectroscopy in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether high-resolution magnetic resonance imaging of the axilla with spectroscopy can identify nodal features suggestive of metastatic involvement in patients diagnosed with invasive breast cancer. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Magnetic Resonance Spectroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Mar 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with recent (within 60 days) invasive breast cancer.
- No previous ipsilateral axillary surgery.
Who cannot join
- Patients diagnosed with in situ disease.
- Patients with previous ipsilateral axillary surgery.
- Patients with MRI/MRA contraindications such as a cardiac pacemaker, an aneurysm clip, cochlear implants, and metal in the eyes.
- Patients who have had a moderate or severe contrast reaction to intravenous gadolinium-DTPA.
- Patients who are clinically not stable.
- Patients who cannot give consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mammography Clinic - UNC Hospitals
Chapel Hill, North Carolina, 27514
About this study
Official title: High-Resolution Axillary MRI With Magnetic Resonance Spectroscopy as a Non-Invasive Test for Determining Pathologic Lymph Node Status in Patients With Invasive Breast Cancer
The purpose of this study is to evaluate whether high-resolution magnetic resonance imaging of the axilla with spectroscopy can identify nodal features suggestive of metastatic involvement in patients diagnosed with invasive breast cancer. This may enable us to define a select group of patients for whom axillary lymph node dissection could be avoided.
Read the detailed description
Breast cancer is the second leading cause of death in women. The spread of cancer from the breast to the lymph nodes is a significant factor in determining breast cancer survival. Currently, surgical procedures are performed to determine lymph node involvement. Full axillary lymph node dissection has a high morbidity associated with the procedure. While sentinel lymphadenectomy avoids a full axillary dissection in clinically negative axilla in untreated patients, it has been reported to have a false negative rate of less than 10%. Others have reported higher false negative rates after neoadjuvant chemotherapy. For those reasons, there is considerable interest in non-invasive methods that may allow staging of the axilla.
Magnetic resonance imaging (MRI) of the breast with contrast-enhancement is increasingly being used in breast cancer patients to determine the size of the tumor and its extent. A few reports from Europe have been published regarding its use in evaluating axillary lymph node metastases preoperatively, and the results appear promising. Kvistad et al. demonstrated lymph node metastases using dynamic contrast-enhanced MRI, in which the study had a sensitivity of 83%, a specificity of 90%, and an accuracy of 88%. Luciani et al, suggest that lymph nodes with a large size, irregular contours, round hila, high-signal intensity on T2 sequences, and those with marked enhancement are associated with malignancy.
Magnetic resonance imaging with spectroscopy (MRS) has been used in clinical practice for evaluation of brain tumors as a method for noninvasive detection of tumor metabolism. More recently, it has been used on other soft-tissue tumors, including breast. Like other soft-tissue tumors, breast cancers have increased levels of the amino acid choline. In several studies, the sensitivity and specificity of MRS for detecting breast cancer ranged from 73%-92% and 71%-93%, respectively. No known MRS data has been published regarding axillary lymph node involvement in patients with breast cancer. It is postulated that the choline peak should be elevated in lymph nodes with metastatic breast cancer.
This is an observational study. All eligible patients who give informed consent will complete a MRI/MRS screening questionnaire and if there are no contraindications will undergo MRI/MRS imaging prior to their clinically indicated sentinel lymphadenectomy which may be followed by axillary dissection to be determined by surgeon during the course of surgery.
- Conditions
- Breast Cancer
- Being tested
- Magnetic Resonance Spectroscopy
- Keywords
- Breast Cancer Staging
- 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 SpectroscopyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2006 (estimated)
- Study startMar 2005
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Lack of funding.
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 UNC Lineberger Comprehensive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cherie M Kuzmiak, D.O., Principal investigator, Department of Radiology, University of North Carolina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312637
- Sponsor's protocol ID
- LCCC0426
- Status last verified
- Apr 2012
- First submitted
- 6 Apr 2006
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Resolution Axillary MRI With Magnetic Resonance Spectroscopy as a Non-Invasive Test for Determining Pathologic Lymph Node Status in Patients With Invasive Breast Cancer
- ClinicalTrials.gov ID
- NCT00312637
- Acronym / sponsor ID
- LCCC0426
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer Staging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Apr 2006 (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 purpose of this study is to evaluate whether high-resolution magnetic resonance imaging of the axilla with spectroscopy can identify nodal features suggestive of metastatic involvement in patients diagnosed with invasive breast cancer. This may enable us to define a select group of patients for whom axillary lymph node dissection could be avoided.
Detailed description
Breast cancer is the second leading cause of death in women. The spread of cancer from the breast to the lymph nodes is a significant factor in determining breast cancer survival. Currently, surgical procedures are performed to determine lymph node involvement. Full axillary lymph node dissection has a high morbidity associated with the procedure. While sentinel lymphadenectomy avoids a full axillary dissection in clinically negative axilla in untreated patients, it has been reported to have a false negative rate of less than 10%. Others have reported higher false negative rates after neoadjuvant chemotherapy. For those reasons, there is considerable interest in non-invasive methods that may allow staging of the axilla.
Magnetic resonance imaging (MRI) of the breast with contrast-enhancement is increasingly being used in breast cancer patients to determine the size of the tumor and its extent. A few reports from Europe have been published regarding its use in evaluating axillary lymph node metastases preoperatively, and the results appear promising. Kvistad et al. demonstrated lymph node metastases using dynamic contrast-enhanced MRI, in which the study had a sensitivity of 83%, a specificity of 90%, and an accuracy of 88%. Luciani et al, suggest that lymph nodes with a large size, irregular contours, round hila, high-signal intensity on T2 sequences, and those with marked enhancement are associated with malignancy.
Magnetic resonance imaging with spectroscopy (MRS) has been used in clinical practice for evaluation of brain tumors as a method for noninvasive detection of tumor metabolism. More recently, it has been used on other soft-tissue tumors, including breast. Like other soft-tissue tumors, breast cancers have increased levels of the amino acid choline. In several studies, the sensitivity and specificity of MRS for detecting breast cancer ranged from 73%-92% and 71%-93%, respectively. No known MRS data has been published regarding axillary lymph node involvement in patients with breast cancer. It is postulated that the choline peak should be elevated in lymph nodes with metastatic breast cancer.
This is an observational study. All eligible patients who give informed consent will complete a MRI/MRS screening questionnaire and if there are no contraindications will undergo MRI/MRS imaging prior to their clinically indicated sentinel lymphadenectomy which may be followed by axillary dissection to be determined by surgeon during the course of surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with recent (within 60 days) invasive breast cancer.
- No previous ipsilateral axillary surgery.
Key exclusion criteria (6 listed)
- Patients diagnosed with in situ disease.
- Patients with previous ipsilateral axillary surgery.
- Patients with MRI/MRA contraindications such as a cardiac pacemaker, an aneurysm clip, cochlear implants, and metal in the eyes.
- Patients who have had a moderate or severe contrast reaction to intravenous gadolinium-DTPA.
- Patients who are clinically not stable.
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 Spectroscopy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
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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.
Cherie M Kuzmiak, D.O. principal investigator
Department of Radiology, University of North Carolina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Spectroscopy in people with Breast Cancer, run by UNC Lineberger Comprehensive 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 2 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: withdrawn, as of the sponsor's last update on 1 May 2012. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 1 May 2012.