- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01240681
Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy (IMPACT)
March 10, 2015 updated by: Ontario Clinical Oncology Group (OCOG)
A Pilot Study of Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
The objective of this pilot study is to determine the effectiveness of Fluorothymidine Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women with locally advanced breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
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
-
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Ontario
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Hamilton, Ontario, Canada, L8V5C2
- Juravinski Cancer Centre
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London, Ontario, Canada
- London Health Sciences Centres - London Regional Cancer Program
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Thunder Bay, Ontario, Canada, P7B6V4
- Thunder Bay Regional Health Sciences Centre
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Toronto, Ontario, Canada, M4N3M5
- Sunnybrook Odette Health Sciences Centre
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-
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
Female
Description
Inclusion Criteria:
- Histologic proof of breast cancer (invasive ductal or lobular carcinoma). Breast sarcoma and lymphoma are not eligible.
- Clinical diagnosis of locally advanced breast cancer (Stage IIB (T3,N0,M0), Stage IIIA, IIIB, or IIIC, according to American Joint Committee on Cancer (AJCC) Tumour-Node-Metastasis (TNM) Cancer Staging), including inflammatory breast cancer.
- Ability to undergo neoadjuvant chemotherapy.
Exclusion Criteria:
- Evidence of metastatic disease (identified on chest x-ray, liver ultrasound, bone scan or other imaging tests);
- Previous chemotherapy or hormonal therapy for breast cancer;
- Significant concurrent medical problems that result in the patient being unfit for surgery (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease);
- Known pregnancy or lactating female (e.g. positive serum beta human chorionic gonadotropin (B-hCG) pregnancy test);
- Inability to lie supine for imaging with Positron Emission Tomography (PET);
- Any contraindication to undergoing Magnetic Resonance Imaging (MRI) or PET;
- Currently receiving Antabuse;
- Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
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: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: FLT PET and BOLD MRI scan
All subjects will have the study intervention of FLT PET and BOLD MRI at baseline and after the first cycle of chemotherapy
|
Eligible consenting patients with LABC receiving neoadjuvant chemotherapy (NA CT) will undergo FLT PET, BOLD MRI, and clinical examination of the involved breast including ipsilateral axillary and supraclavicular nodes to assess the treatment response to chemotherapy (CT).
The imaging studies will be performed at baseline and after the first cycle of NA CT.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response (partial and complete)
Time Frame: 6 months (approximately)
|
Partial clinical response refers to at least a 50% reduction in the dimensions of the tumour mass and a complete clinical response refers to complete absence of the mass on physical exam, as well as absence of inflammation, ulceration and peau d'orange.
|
6 months (approximately)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic response
Time Frame: 6 months (approximately)
|
Using the Residual Cancer Burden (RCB) index the pathologic response will be divided into categories.
The three categories are complete response, near complete response and chemotherapy resistance.
A complete pathologic response (pCR) refers to complete absence of invasive cancer.
|
6 months (approximately)
|
Imaging Quantification
Time Frame: 6 months (approximately)
|
Fluorothymidine Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent (BOLD) MRI quantification of tumor responses to predict which patients are likely to achieve a pathologic complete response.
|
6 months (approximately)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Som Mukherjee, Juravinski Cancer Centre Hamilton, Ontario
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
April 1, 2011
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
November 1, 2010
First Submitted That Met QC Criteria
November 11, 2010
First Posted (Estimate)
November 15, 2010
Study Record Updates
Last Update Posted (Estimate)
March 11, 2015
Last Update Submitted That Met QC Criteria
March 10, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCOG-2010-IMPACT
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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