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

Phase 2

Terminated

• Conditions: Breast Neoplasm
• Interventions: Drug: 18F-FAZA PET scan; Drug: FluGlucoScan Injection (18F-FDB) PET scan

• Registration Number: NCT00771381
• Lead Sponsor: AHS Cancer Control Alberta

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 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

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.

Study Timeline

• Study First Submitted: 2008-09-19
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Study Start: 2008-11-28
• Status Verified: 2019-02
• Primary Completion: 2019-02-04
• Study Completion: 2019-02-04
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	18F-FAZA PET scan	18F-FAZA + FluGlucoScan Injection
1	FluGlucoScan Injection (18F-FDB) PET scan	18F-FAZA + FluGlucoScan Injection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
General biodistribution of 18F-FAZA and FluGlucoScan Injection	5 years
Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images	5 years

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada