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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

November 1, 2010
March 11, 2013
April 2011
June 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01240681 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Locally Advanced Breast Cancer (LABC)
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.
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
Intervention: Procedure: FLT PET and BOLD MRI scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
December 2014
June 2013   (final data collection date for primary outcome measure)

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).
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01240681
OCOG-2010-IMPACT
Yes
Ontario Clinical Oncology Group (OCOG)
Ontario Clinical Oncology Group (OCOG)
Not Provided
Principal Investigator: Som Mukherjee Juravinski Cancer Centre Hamilton, Ontario
Ontario Clinical Oncology Group (OCOG)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP