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

• Status: Terminated
• Trial end date: 2019-02-04
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta
• Treatments: Fluoroazomycin arabinoside

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.