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

August 21, 2019 updated by: AHS Cancer Control Alberta

A Phase II Pre-Treatment Hypoxia PET Imaging Study Using 18F-FAZA in Patients With Invasive Duct Carcinoma of the Breast

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
18F-FAZA + FluGlucoScan Injection
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
General biodistribution of 18F-FAZA and FluGlucoScan Injection
Time Frame: 5 years
5 years
Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 28, 2008

Primary Completion (ACTUAL)

February 4, 2019

Study Completion (ACTUAL)

February 4, 2019

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (ESTIMATE)

October 13, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KT-FAZ-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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