Status:
TERMINATED
A Study to Determine the Value of 18F-FAZA PET Imaging in Patients With Breast Cancer
Lead Sponsor:
AHS Cancer Control Alberta
Conditions:
Breast Neoplasm
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
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 clini...
Eligibility Criteria
Inclusion
- 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.
- Pathologically proven invasive duct carcinoma of the breast (FNA or core biopsy), T1-T4(T ≥ 1.5 cm)
- FluGlucoScan Injection and 18F-FAZA PET scans performed prior to treatment.
- FluGlucoScan Injection and 18F-FAZA PET scans performed within 4 weeks prior to their definitive surgery if subject does not have neoadjuvant therapy.
- Able and willing to follow instructions and comply with the protocol
- Provide written informed consent prior to participation in the study.
- ECOG performance score ≤ 2
Exclusion
- Previous malignancy or diagnosis less than ten (10) years ago. Skin Cancers (excluding malignant melanoma) and carcinoma in situ of the cervix are exceptions.
- Excisional biopsy of the primary breast tumour has been performed
- Women with an invasive carcinoma of the breast that is not predominantly of the invasive duct subtype
- Primary breast carcinoma previously treated.
- Women who are nursing or pregnant.
Key Trial Info
Start Date :
November 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00771381
Start Date
November 28 2008
End Date
February 4 2019
Last Update
August 22 2019
Active Locations (1)
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1
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2