A Study to Determine the Value of 18F-FAZA PET Imaging in... | NCT00771381

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

NCT00771381

Sponsor

AHS Cancer Control Alberta

Status

Terminated

Last Update Posted

Aug 22, 2019Actual

Enrollment

23Actual

Phase

Phase 2

Conditions

Breast Neoplasm

Interventions

18F-FAZA PET scan
FluGlucoScan Injection (18F-FDB) PET scan

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Retirement of former Qualified Investigator and lack of resources to complete study

Expanded Access Info

Start Date

Nov 28, 2008Actual

Primary Completion Date

Feb 4, 2019Actual

Completion Date

Feb 4, 2019Actual

First Submitted Date

Sep 19, 2008

First Submission Date that Met QC Criteria

Oct 10, 2008

First Posted Date

Oct 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2019

Last Update Posted Date

Aug 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	18F-FAZA + FluGlucoScan Injection	Drug: 18F-FAZA PET scan Drug: FluGlucoScan Injection (18F-FDB) PET scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
18F-FAZA PET scan	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.	1

Outcomes Module

Primary Outcomes

Measure	Description	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.		5 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Emmanuel W Hudson, MD	Cross Cancer Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cross Cancer Institute		Edmonton	Alberta	T6G 1Z2	Canada

ID	Term
D001943	Breast Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

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Browse Branches

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