NCT00771381

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2008

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 13, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2008

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2019

Completed
Last Updated

August 22, 2019

Status Verified

February 1, 2019

Enrollment Period

10.2 years

First QC Date

September 19, 2008

Last Update Submit

August 21, 2019

Conditions

Breast Neoplasm

Keywords

18F-FAZA18F-FDGPositron Emission TomographyCell Hypoxia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • General biodistribution of 18F-FAZA and FluGlucoScan Injection

    5 years

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

    5 years

Study Arms (1)

1

EXPERIMENTAL

18F-FAZA + FluGlucoScan Injection

Drug: 18F-FAZA PET scanDrug: FluGlucoScan Injection (18F-FDB) PET scan

Interventions

18F-FAZA PET scanDRUG

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.

1
FluGlucoScan Injection (18F-FDB) PET scanDRUG

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

1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Emmanuel W Hudson, MD

    Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2008

First Posted

October 13, 2008

Study Start

November 28, 2008

Primary Completion

February 4, 2019

Study Completion

February 4, 2019

Last Updated

August 22, 2019

Record last verified: 2019-02

Locations

CA(1)