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

AHS Cancer Control Alberta

Status and phase: Terminated; Phase 2

Conditions: Breast Neoplasm

Treatments: Drug: FluGlucoScan Injection (18F-FDB) PET scan; Drug: 18F-FAZA PET scan

Study type: Interventional

Funder types: Other

Identifiers

NCT00771381

KT-FAZ-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

1

Experimental group

Description:

18F-FAZA + FluGlucoScan Injection

Treatment:

Drug: 18F-FAZA PET scan

Drug: FluGlucoScan Injection (18F-FDB) PET scan