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

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

    • Ontario
      • Hamilton, Ontario, Canada, L8V5C2
        • Juravinski Cancer Centre
      • London, Ontario, Canada
        • London Health Sciences Centres - London Regional Cancer Program
      • Thunder Bay, Ontario, Canada, P7B6V4
        • Thunder Bay Regional Health Sciences Centre
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Odette Health Sciences Centre

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

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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