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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Locally Advanced Breast Cancer (LABC)

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Clinical response (partial and complete)

Outcome 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.

Outcome Time Frame:

6 months (approximately)

Safety Issue:

No

Principal Investigator

Som Mukherjee

Investigator Role:

Principal Investigator

Investigator Affiliation:

Juravinski Cancer Centre Hamilton, Ontario

Authority:

Canada: Health Canada

Study ID:

OCOG-2010-IMPACT

NCT ID:

NCT01240681

Start Date:

April 2011

Completion Date:

December 2014

Related Keywords:

  • Locally Advanced Breast Cancer (LABC)
  • 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
  • Breast Neoplasms

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