A Study to Determine the Value of 18F-FAZA PET Imaging in Patients With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771381
Recruitment Status : Unknown
Verified March 2012 by AHS Cancer Control Alberta.
Recruitment status was:  Recruiting
First Posted : October 13, 2008
Last Update Posted : October 3, 2014
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Brief Summary:
In about half the cases of breast cancer, there is hypoxic (no, or little oxygen) tissue present. Hypoxic cells can be resistant to treatment and may cause increased tumour growth. This study will use 18F-FAZA PET scans before surgery or treatment to assess whether patients have hypoxic tumours. The results will be compared to tissue samples removed during surgery and to the distribution of 18F-FDG.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: 18F-FAZA PET scan Drug: FluGlucoScan Injection (18F-FDB) PET scan Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase II Pre-Treatment Hypoxia PET Imaging Study Using 18F-FAZA in Patients With Invasive Duct Carcinoma of the Breast
Study Start Date : November 2008
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1
18F-FAZA + FluGlucoScan Injection
Drug: 18F-FAZA PET scan
Radioactive dose of 18F-FAZA: 110-600 MBq per injection. One pre-treatment injection of 18F-FAZA and PET scan will be permitted per patient.

Drug: FluGlucoScan Injection (18F-FDB) PET scan
Radioactive dose of 100-700 MBq per injection. A single pre-treatment injection of FluGlucoScan Injection and PET scan will be permitted per patient.

Primary Outcome Measures :
  1. 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. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. General biodistribution of 18F-FAZA and FluGlucoScan Injection [ Time Frame: 5 years ]
  2. Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00771381

Contact: Lai Schrader 780.432.8464
Contact: Margaret Landon 780.432.8751

Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Sub-Investigator: Katia Tonkin, MD         
Principal Investigator: Alexander J.B. McEwan, MB         
Sub-Investigator: Kelly Dabbs, MD         
Sub-Investigator: Emmanuel Hudson, MD         
Sponsors and Collaborators
AHS Cancer Control Alberta
Principal Investigator: Alexander J.B. McEwan, MB,BS,MSc Cross Cancer Institute
Principal Investigator: Katia Tonkin, MBBS Cross Cancer Institute

Additional Information:
Responsible Party: AHS Cancer Control Alberta Identifier: NCT00771381     History of Changes
Other Study ID Numbers: BR-24334/KT-FAZ-004
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: March 2012

Keywords provided by AHS Cancer Control Alberta:
Positron Emission Tomography
Cell Hypoxia

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases