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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Breast Neoplasm

Intervention / Treatment
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* Drug: 18F-FAZA PET scan
* Drug: FluGlucoScan Injection (18F-FDB) PET scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>18F-FAZA + FluGlucoScan Injection | Drug: 18F-FAZA PET scan<br>* 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.<br>Drug: FluGlucoScan Injection (18F-FDB) PET scan<br>* Radioactive dose of 100-700 MBq per injection. A single pre-treatment injection of FluGlucoScan Injection and PET scan will be permitted per patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General biodistribution of 18F-FAZA and FluGlucoScan Injection |  | 5 years | 
| Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-FAZA, 18F-FDG, Positron Emission Tomography, Cell Hypoxia