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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT01240681
First received: November 1, 2010
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Locally Advanced Breast Cancer (LABC)
 Procedure: FLT PET and BOLD MRI scan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • Clinical response (partial and complete) [ Time Frame: 6 months (approximately) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months (approximately) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01240681

Locations
Canada, Ontario
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
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Investigators
Principal Investigator: Som Mukherjee Juravinski Cancer Centre Hamilton, Ontario
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT01240681     History of Changes
Other Study ID Numbers: OCOG-2010-IMPACT
Study First Received: November 1, 2010
Last Updated: March 11, 2013
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013