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

Primary Purpose

Breast Neoplasm

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
18F-FAZA PET scan
FluGlucoScan Injection (18F-FDB) PET scan
Sponsored by
AHS Cancer Control Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasm focused on measuring 18F-FAZA, 18F-FDG, Positron Emission Tomography, Cell Hypoxia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Cross Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

18F-FAZA + FluGlucoScan Injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

General biodistribution of 18F-FAZA and FluGlucoScan Injection
Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images

Full Information

First Posted
September 19, 2008
Last Updated
August 21, 2019
Sponsor
AHS Cancer Control Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT00771381
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Retirement of former Qualified Investigator and lack of resources to complete study
Study Start Date
November 28, 2008 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
February 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
Keywords
18F-FAZA, 18F-FDG, Positron Emission Tomography, Cell Hypoxia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
18F-FAZA + FluGlucoScan Injection
Intervention Type
Drug
Intervention Name(s)
18F-FAZA PET scan
Intervention Description
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
Intervention Name(s)
FluGlucoScan Injection (18F-FDB) PET scan
Intervention Description
Radioactive dose of 100-700 MBq per injection. A single pre-treatment injection of FluGlucoScan Injection and PET scan will be permitted per patient.
Primary Outcome Measure Information:
Title
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
General biodistribution of 18F-FAZA and FluGlucoScan Injection
Time Frame
5 years
Title
Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Pathologically proven invasive duct carcinoma of the breast (FNA or core biopsy), T1-T4(T ≥ 1.5 cm) FluGlucoScan Injection and 18F-FAZA PET scans performed prior to treatment. FluGlucoScan Injection and 18F-FAZA PET scans performed within 4 weeks prior to their definitive surgery if subject does not have neoadjuvant therapy. Able and willing to follow instructions and comply with the protocol Provide written informed consent prior to participation in the study. ECOG performance score ≤ 2 Exclusion Criteria: Previous malignancy or diagnosis less than ten (10) years ago. Skin Cancers (excluding malignant melanoma) and carcinoma in situ of the cervix are exceptions. Excisional biopsy of the primary breast tumour has been performed Women with an invasive carcinoma of the breast that is not predominantly of the invasive duct subtype Primary breast carcinoma previously treated. Women who are nursing or pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel W Hudson, MD
Organizational Affiliation
Cross Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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