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

This study is currently recruiting participants.
Verified March 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00771381
First received: September 19, 2008
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • General biodistribution of 18F-FAZA and FluGlucoScan Injection [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771381

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

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Contact     780-432-8464     clinical_trials_cci@cancerboard.ab.ca    
Sub-Investigator: Katia Tonkin, MD            
Principal Investigator: Alexander J.B. McEwan, MB            
Sub-Investigator: Kelly Dabbs, MD            
Sub-Investigator: Emmanuel Hudson, BMedSc, MD            
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Alexander J.B. McEwan, MB,BS,MSc Cross Cancer Institute
Principal Investigator: Katia Tonkin, MBBS Cross Cancer Institute
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT00771381     History of Changes
Other Study ID Numbers: BR-24334/KT-FAZ-004
Study First Received: September 19, 2008
Last Updated: March 16, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
18F-FAZA
18F-FDG
Positron Emission Tomography
Cell Hypoxia

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

ClinicalTrials.gov processed this record on May 23, 2013