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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)

Primary Purpose

Locally Advanced Breast Cancer (LABC)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FLT PET and BOLD MRI scan
Sponsored by
Ontario Clinical Oncology Group (OCOG)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Locally Advanced Breast Cancer (LABC) focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Juravinski Cancer Centre
  • London Health Sciences Centres - London Regional Cancer Program
  • Thunder Bay Regional Health Sciences Centre
  • Sunnybrook Odette Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FLT PET and BOLD MRI scan

Arm Description

All subjects will have the study intervention of FLT PET and BOLD MRI at baseline and after the first cycle of chemotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 1, 2010
Last Updated
March 10, 2015
Sponsor
Ontario Clinical Oncology Group (OCOG)
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1. Study Identification

Unique Protocol Identification Number
NCT01240681
Brief Title
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
Acronym
IMPACT
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ontario Clinical Oncology Group (OCOG)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Breast Cancer (LABC)
Keywords
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FLT PET and BOLD MRI scan
Arm Type
Other
Arm Description
All subjects will have the study intervention of FLT PET and BOLD MRI at baseline and after the first cycle of chemotherapy
Intervention Type
Procedure
Intervention Name(s)
FLT PET and BOLD MRI scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical response (partial and complete)
Description
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.
Time Frame
6 months (approximately)
Secondary Outcome Measure Information:
Title
Pathologic response
Description
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.
Time Frame
6 months (approximately)
Title
Imaging Quantification
Description
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.
Time Frame
6 months (approximately)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Som Mukherjee
Organizational Affiliation
Juravinski Cancer Centre Hamilton, Ontario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
London Health Sciences Centres - London Regional Cancer Program
City
London
State/Province
Ontario
Country
Canada
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B6V4
Country
Canada
Facility Name
Sunnybrook Odette Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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