Breast CancerNCT01045044
Magnetic Resonance Imaging (MRI) of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Chemotherapy
An observational study of Breast Cancer, run by Kettering Health Network at 2 sites in United States.
Trial summary
We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Oct 2011
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast cancer cohort will be patients of Medical Oncology Hematology Associates Inc., Dayton, OH Normal controls will be recruited from Kettering College of Medical Arts and the Kettering Health Network.
Who may be able to join
- Diagnosed with Adenocarcinoma(ER+ve, PR+ve)
- Prescribed, but not yet begun, anthracycline based systemic chemotherapy
- Not prescribed Avastin
- Able to read and write in English
- Have signed informed consent
Who cannot join
- Diagnosed psychiatric disorder
- Conditions that would preclude MRI (Pacemaker, metal objects in body, claustrophobia, pregnancy, etc.)
- Serious, unstable medical or mental illness
- Medical contraindication to any study procedure
- Current alcohol or other substance use disorder (excluding nicotine)
- Have not read and signed informed consent, or do not understand its contents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical Oncology Hematology Associates, Inc
Dayton, Ohio, 45408
Innovation Center, Kettering Health Network
Kettering, Ohio, 45429
About this study
Official title: Magnetic Resonance Imaging of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Anthracycline-based Systemic Chemotherapy
We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these women. The results will be compared to a control group of normal healthy women. We will try to determine if MRI can be used to predict tumor response and cognitive changes related to the chemotherapy.
Read the detailed description
In this work we will utilize conventional magnetic resonance imaging as well as a set of advanced magnetic resonance imaging tools to investigate changes in tumor physiology and the human brain resulting from anthracycline-based systemic chemotherapy. We will recruit up to 15 subjects diagnosed with breast cancer and preparing for an anthracycline-based systemic chemotherapy regimen. Each subject will undergo the set of MR imaging tools before therapy, after one therapy session, after four therapy sessions, and at the conclusion of therapy. Conventional MRI methods will be used to quantify tumor-response to chemotherapy for each subject. A control group of up to 15 normal subjects will also be recruited and will undergo MR brain imaging twice with a gap of 6 months between scans. All subjects will also undergo a battery of neuropsychological tests at each imaging session. The results of the neuropsychological tests will be used to quantify cognitive changes for each subject. A final analysis will determine if the advanced MR modalities can be used to predict the response of tumors or human cognition to chemotherapy.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Magnetic Resonance Imaging, Anthracycline based systemic chemotherapy, Tumor response, Cognitive Impairment, Chemo Brain
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction
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 |
|---|---|---|
| Breast cancer, chemotherapy | Up to 15 women with breast cancer who are to undergo systemic anthracycline based chemotherapy. | |
| Normal control | Up to 15 normal, healthy women. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: No participants enrolled
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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Investigators
- Jason Parker, PhD, Principal investigator, Kettering Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045044
- Sponsor's protocol ID
- KHNIC-P09-004
- Status last verified
- Apr 2012
- First submitted
- 6 Jan 2010
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging of Tumor Response and Cognitive Impairment in Breast Cancer Patients Undergoing Anthracycline-based Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT01045044
- Acronym / sponsor ID
- KHNIC-P09-004
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Magnetic Resonance Imaging, Anthracycline based systemic chemotherapy, Tumor response, Cognitive Impairment, Chemo Brain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Jan 2010 (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.
We will use magnetic resonance imaging (MRI) to investigate tumor changes in women with breast cancer who are receiving anthracycline-based systemic chemotherapy. We will also use MRI and cognitive tests to study the possible effects of chemotherapy on the brains of these women. The results will be compared to a control group of normal healthy women. We will try to determine if MRI can be used to predict tumor response and cognitive changes related to the chemotherapy.
Detailed description
In this work we will utilize conventional magnetic resonance imaging as well as a set of advanced magnetic resonance imaging tools to investigate changes in tumor physiology and the human brain resulting from anthracycline-based systemic chemotherapy. We will recruit up to 15 subjects diagnosed with breast cancer and preparing for an anthracycline-based systemic chemotherapy regimen. Each subject will undergo the set of MR imaging tools before therapy, after one therapy session, after four therapy sessions, and at the conclusion of therapy. Conventional MRI methods will be used to quantify tumor-response to chemotherapy for each subject. A control group of up to 15 normal subjects will also be recruited and will undergo MR brain imaging twice with a gap of 6 months between scans. All subjects will also undergo a battery of neuropsychological tests at each imaging session. The results of the neuropsychological tests will be used to quantify cognitive changes for each subject. A final analysis will determine if the advanced MR modalities can be used to predict the response of tumors or human cognition to chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast cancer, chemotherapy | – | –Up to 15 women with breast cancer who are to undergo systemic anthracycline based chemotherapy. |
| Normal control | – | –Up to 15 normal, healthy women. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer cohort will be patients of Medical Oncology Hematology Associates Inc., Dayton, OH Normal controls will be recruited from Kettering College of Medical Arts and the Kettering Health Network.
Key inclusion criteria (5 listed)
- Diagnosed with Adenocarcinoma(ER+ve, PR+ve)
- Prescribed, but not yet begun, anthracycline based systemic chemotherapy
- Not prescribed Avastin
- Able to read and write in English
- Have signed informed consent
Key exclusion criteria (6 listed)
- Diagnosed psychiatric disorder
- Conditions that would preclude MRI (Pacemaker, metal objects in body, claustrophobia, pregnancy, etc.)
- Serious, unstable medical or mental illness
- Medical contraindication to any study procedure
- Current alcohol or other substance use disorder (excluding nicotine)
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 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.
Jason Parker, PhD principal investigator
Kettering Health Network
2 sites 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 Kettering Health Network at 2 sites 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 5 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 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 5 Apr 2012.