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

Not Applicable

Completed

• Conditions: Locally Advanced Breast Cancer (LABC)
• Interventions: Procedure: FLT PET and BOLD MRI scan

• Registration Number: NCT01240681
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-11
• Study First Posted: 2010-11-15
• Study Start: 2011-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-10
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FLT PET and BOLD MRI scan	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

Primary Outcome Measures

Name	Time	Method
Clinical response (partial and complete)	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.

Secondary Outcome Measures

Name	Time	Method
Pathologic response	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	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.

Trial Locations

Locations (4)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Thunder Bay Regional Health Sciences Centre; 🇨🇦 Thunder Bay, Ontario, Canada

London Health Sciences Centres - London Regional Cancer Program; 🇨🇦 London, Ontario, Canada

Sunnybrook Odette Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada