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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by AHS Cancer Control Alberta.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: October 13, 2008
Last Update Posted: October 3, 2014
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.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
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 Intervention Phase
Breast Neoplasm Drug: 18F-FAZA PET scan Drug: FluGlucoScan Injection (18F-FDB) PET scan Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AHS Cancer Control Alberta:

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

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00771381

Contact: Lai Schrader 780.432.8464 Lai.Schrader@albertahealthservices.ca
Contact: Margaret Landon 780.432.8751 Margaret.Landon@albertahealthservices.ca

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
  More Information

Additional Information:
Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00771381     History of Changes
Other Study ID Numbers: BR-24334/KT-FAZ-004
First Submitted: September 19, 2008
First Posted: October 13, 2008
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