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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Locally Advanced Breast Cancer (LABC)

Intervention / Treatment
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* Procedure: FLT PET and BOLD MRI scan


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FLT PET and BOLD MRI scan<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response (partial and complete) | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Locally Advanced Breast Cancer (LABC), neoadjuvant chemotherapy, Fluorothymidine Positron Emission Tomography (FLT PET), Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI), tumor response, mastectomy