NCT01240681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

3.8 years

First QC Date

November 1, 2010

Last Update Submit

March 10, 2015

Conditions

Locally Advanced Breast Cancer (LABC)

Keywords

Locally Advanced Breast Cancer (LABC)neoadjuvant chemotherapyFluorothymidine Positron Emission Tomography (FLT PET)Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI)tumor responsemastectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months (approximately)

Secondary Outcomes (2)

  • Pathologic response

    6 months (approximately)

  • Imaging Quantification

    6 months (approximately)

Study Arms (1)

FLT PET and BOLD MRI scan

OTHER

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

Interventions

FLT PET and BOLD MRI scanPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Juravinski Cancer Centre

Hamilton, Ontario, L8V5C2, Canada

Location

London Health Sciences Centres - London Regional Cancer Program

London, Ontario, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B6V4, Canada

Location

Sunnybrook Odette Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Study Officials

  • Som Mukherjee

    Juravinski Cancer Centre Hamilton, Ontario

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 15, 2010

Study Start

April 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

CA(4)