Clinical trial NCT00771381: A Study to Determine the Value of 18F-FAZA PET Imaging in Patients With Breast Cancer
Official title: A Phase II Pre-Treatment Hypoxia PET Imaging Study Using 18F-FAZA in Patients With Invasive Duct Carcinoma of the Breast
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasm
Keywords: 18F-FAZA
18F-FDG
Positron Emission Tomography
Cell Hypoxia
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2008-10-13
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 5 years
Secondary outcomes:
measure: General biodistribution of 18F-FAZA and FluGlucoScan Injection
timeFrame: 5 years
measure: Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images
timeFrame: 5 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Cross Cancer Institute
name: Emmanuel W Hudson, MD
role: PRINCIPAL_INVESTIGATOR
References: