- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01428739
Correlation Between MRS (Magnetic Resonance Spectroscopy) and Tumor Response to Radiation Therapy in Breast Cancer
January 23, 2017 updated by: AHS Cancer Control Alberta
Correlation between MRS and Tumor Response Therapy in Breast Cancer.
Study Overview
Detailed Description
Correlation between MRS (Magnetic Resonance Spectroscopy and Tumor Response to Radiation in Breast Cancer
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 1Z2
- Cross Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed diagnosed Breast cancer
- Patient is 18 years or older
- Karnofsky performance score > 70
- No previously irradiated or recurrent breast cancer
- No contraindication to MRS/MRI
- Signed informed consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MRS Correlation with Treatment Response
Time Frame: Up to One Year
|
measuring choline, water and fat levels by proton magnetic resonance spectroscopy in breast tumors in response to treatment
|
Up to One Year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation with Tumor Stage
Time Frame: Up to One year
|
Up to One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nadeem Pervez, MBBS, FFRRCSI, FRCPC, Cross Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
October 21, 2010
First Submitted That Met QC Criteria
September 2, 2011
First Posted (Estimate)
September 5, 2011
Study Record Updates
Last Update Posted (Estimate)
January 25, 2017
Last Update Submitted That Met QC Criteria
January 23, 2017
Last Verified
October 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23701
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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