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

NCT ID: NCT00771381

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-28
• Study Completion Date: 2019-02-04

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.

Conditions

Breast Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

18F-FAZA + FluGlucoScan Injection

Group Type: EXPERIMENTAL

18F-FAZA PET scan

Intervention Type: DRUG

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

Intervention Type: DRUG

Radioactive dose of 100-700 MBq per injection. A single pre-treatment injection of FluGlucoScan Injection and PET scan will be permitted per patient.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel W Hudson, MD

Role: PRINCIPAL_INVESTIGATOR

Cross Cancer Institute

Locations

Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

KT-FAZ-004

Identifier Type: -

Identifier Source: org_study_id