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A Phase II Pre-Treatment Hypoxia PET Imaging Study Using 18F-FAZA in Patients With Invasive Duct Carcinoma of the Breast

Phase 2
18 Years
Open (Enrolling)
Breast Neoplasm

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Trial Information

A Phase II Pre-Treatment Hypoxia PET Imaging Study Using 18F-FAZA in Patients With Invasive Duct Carcinoma of the Breast

Hypoxia or anoxia can be found in 50% of locally advanced breast carcinomas. Assessment of
pre-treatment in viva and in vitro hypoxia could allow patient selection for more aggressive
therapy or clinical trails focused on targeting hypoxia. We will use the PET radiotracer
18F-FAZA to monitor hypoxia in the protocol. We will study pathological characteristics on
the final tumour restriction specimen and correlate prognostic and predictive factors with
PET scan data. Tumour banking is optional.

Inclusion Criteria:

1. Female ≥ 18 years of age. If female of child bearing potential and if outside of the
window of 10 days since the first day of the 0last menstrual period, patient will be
required to have a negative pregnancy test.

2. Pathologically proven invasive duct carcinoma of the breast (FNA or core biopsy),
T1-T4(T ≥ 1.5 cm)

3. FluGlucoScan Injection and 18F-FAZA PET scans performed prior to treatment.

4. FluGlucoScan Injection and 18F-FAZA PET scans performed within 4 weeks prior to their
definitive surgery if subject does not have neoadjuvant therapy.

5. Able and willing to follow instructions and comply with the protocol

6. Provide written informed consent prior to participation in the study.

7. ECOG performance score ≤ 2

Exclusion Criteria:

1. Previous malignancy or diagnosis less than ten (10) years ago. Skin Cancers
(excluding malignant melanoma) and carcinoma in situ of the cervix are exceptions.

2. Excisional biopsy of the primary breast tumour has been performed

3. Women with an invasive carcinoma of the breast that is not predominantly of the
invasive duct subtype

4. Primary breast carcinoma previously treated.

5. Women who are nursing or pregnant.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Uptake of 18F-FAZA (RUS and T/B) and its correlation to tumour size, auxiliary nodal status, tumour grade, EP/PR, and HER-2 status, Ki-67, Androgen receptor status (AR), vimentin and basal keratins, HIF-1 a and glomeruloid microvascular proliferation.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Alexander J.B. McEwan, MB,BS,MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cross Cancer Institute


Canada: Health Canada

Study ID:




Start Date:

November 2008

Completion Date:

June 2013

Related Keywords:

  • Breast Neoplasm
  • 18F-FAZA
  • 18F-FDG
  • Positron Emission Tomography
  • Cell Hypoxia
  • Breast Neoplasms
  • Neoplasms