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)
|ClinicalTrials.gov Identifier: NCT01240681|
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : March 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Breast Cancer (LABC)||Procedure: FLT PET and BOLD MRI scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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
Procedure: FLT PET and BOLD MRI scan
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240681
|Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V5C2|
|London Health Sciences Centres - London Regional Cancer Program|
|London, Ontario, Canada|
|Thunder Bay Regional Health Sciences Centre|
|Thunder Bay, Ontario, Canada, P7B6V4|
|Sunnybrook Odette Health Sciences Centre|
|Toronto, Ontario, Canada, M4N3M5|
|Principal Investigator:||Som Mukherjee||Juravinski Cancer Centre Hamilton, Ontario|