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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00771381
Other study ID # KT-FAZ-004
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 28, 2008
Est. completion date February 4, 2019

Study information

Verified date February 2019
Source AHS Cancer Control Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date February 4, 2019
Est. primary completion date February 4, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
18F-FAZA PET scan
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.
FluGlucoScan Injection (18F-FDB) PET scan
Radioactive dose of 100-700 MBq per injection. A single pre-treatment injection of FluGlucoScan Injection and PET scan will be permitted per patient.

Locations

Country Name City State
Canada Cross Cancer Institute Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 General biodistribution of 18F-FAZA and FluGlucoScan Injection 5 years
Secondary Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images 5 years
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