Breast TumorsNCT00639171
Evaluate the Use of the Magnetic Resonance Spectroscopy in Determining if the Breast Tumor is Benign or Malignant
An observational study of Breast Tumors, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of biochemical properties of tissue. While MRS does not generate images of tumor per se it allows biochemical spectroscopic data to be obtained in vivo from user defined region-of-interest. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Tumors
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 2015
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be recruited from two ongoing clinical studies of the breast at SUNY Upstate Medical University.
Who may be able to join
- subjects should have well defined suspicious breast lesion and that will be biopsied
- subjects are to include; varied volunteers with different breast tissue with characteristics such as dense breasts, fibrocystic breasts, "small" breasted and "large" breasted women.
Who cannot join
- Women of childbearing potential who are not practicing a medically accepted method of birth control should not participate
- Subjects that are pregnant, breast-feeding, should not be able to participate
- Subjects having any of the following metallic devices, will be ineligible to participate in the study: pacemaker, prosthesis, artificial heart valve, coronary artery stents, TENS (Transcutaneous electric nerve stimulator) or other neurological stimulation units and surgical clips.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Clinical Implementation and Evaluation of MR Spectroscopy for Breast Cancer Detection
Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of biochemical properties of tissue. While MRS does not generate images of tumor per se it allows biochemical spectroscopic data to be obtained in vivo from user defined region-of-interest. In this manner, biochemical information elucidated by MRS can be interpreted in relation to detailed anatomy and images of metabolite distribution can be created. The aim of MRS is to identify presence and concentration of metabolites characteristic for normal and abnormal (tumor) cellular activities hence allow differential normal tissue from pathological tissue, as well as allow differentiating malignant from benign tumors.
Read the detailed description
Recent in vivo studies have reported successful use of 1H and 31P MRS in differentiating between benign and malignant tumors in breast tissue. These studies demonstrated an increase in the choline metabolite peak that reflects an increase in choline-containing metabolites in 70-80% of breast carcinomas, as compared to 14-18% of benign breast tumors.The objectives would be to determine sensitivity/specificity of MRS in the context of breast CA, We will use normal volunteers to test software and to develop and optimize MR scan sequences prior to or during the testing of target subjects with suspicious breast lesion.
- Conditions
- Breast Tumors
- Keywords
- breast, diagnostic radiology, suspicious breast tumors, 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects with suspicious breast lesions that warrant further evaluation will be followed to determination and confirmation of diagnosis. | |
| 2 | Normal subjects used to evaluate software and to develop and optimize MR sequences will be examined. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startNov 2005
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast TumorsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrzej Krol, State University of New York - Upstate Medical University
- Investigators
- Andrzej Krol, PhD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639171
- Sponsor's protocol ID
- SUNYUMU 4909
- Status last verified
- Dec 2023
- First submitted
- 12 Mar 2008
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implementation and Evaluation of MR Spectroscopy for Breast Cancer Detection
- ClinicalTrials.gov ID
- NCT00639171
- Acronym / sponsor ID
- SUNYUMU 4909
- Conditions
- Breast Tumors
- Keywords
- breast, diagnostic radiology, suspicious breast tumors, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Nov 2005 (actual)
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 20 Mar 2008 (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.
Magnetic Resonance Spectroscopy (MRS) is a novel imaging technique for noninvasive probing of biochemical properties of tissue. While MRS does not generate images of tumor per se it allows biochemical spectroscopic data to be obtained in vivo from user defined region-of-interest. In this manner, biochemical information elucidated by MRS can be interpreted in relation to detailed anatomy and images of metabolite distribution can be created. The aim of MRS is to identify presence and concentration of metabolites characteristic for normal and abnormal (tumor) cellular activities hence allow differential normal tissue from pathological tissue, as well as allow differentiating malignant from benign tumors.
Detailed description
Recent in vivo studies have reported successful use of 1H and 31P MRS in differentiating between benign and malignant tumors in breast tissue. These studies demonstrated an increase in the choline metabolite peak that reflects an increase in choline-containing metabolites in 70-80% of breast carcinomas, as compared to 14-18% of benign breast tumors.The objectives would be to determine sensitivity/specificity of MRS in the context of breast CA, We will use normal volunteers to test software and to develop and optimize MR scan sequences prior to or during the testing of target subjects with suspicious breast lesion.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects with suspicious breast lesions that warrant further evaluation will be followed to determination and confirmation of diagnosis. |
| 2 | – | –Normal subjects used to evaluate software and to develop and optimize MR sequences will be examined. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from two ongoing clinical studies of the breast at SUNY Upstate Medical University.
Key inclusion criteria (2 listed)
- subjects should have well defined suspicious breast lesion and that will be biopsied
- subjects are to include; varied volunteers with different breast tissue with characteristics such as dense breasts, fibrocystic breasts, "small" breasted and "large" breasted women.
Key exclusion criteria (3 listed)
- Women of childbearing potential who are not practicing a medically accepted method of birth control should not participate
- Subjects that are pregnant, breast-feeding, should not be able to participate
- Subjects having any of the following metallic devices, will be ineligible to participate in the study: pacemaker, prosthesis, artificial heart valve, coronary artery stents, TENS (Transcutaneous electric nerve stimulator) or other neurological stimulation units and surgical clips.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 14 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Andrzej Krol, PhD principal investigator
State University of New York - Upstate Medical University
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 Tumors, run by State University of New York - Upstate Medical University 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 3 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 14 Dec 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.
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 14 Dec 2023.