Clinical trial NCT01240681: 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
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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).

Primary outcomes:
measure: Clinical response (partial and complete)
timeFrame: 6 months (approximately)
Secondary outcomes:
measure: Pathologic response
timeFrame: 6 months (approximately)
measure: Imaging Quantification
timeFrame: 6 months (approximately)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centres - London Regional Cancer Program
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Odette Health Sciences Centre
state: Ontario
Study officials:
affiliation: Juravinski Cancer Centre Hamilton, Ontario
name: Som Mukherjee
role: PRINCIPAL_INVESTIGATOR
References: