Breast NeoplasmPhase 2NCT00771381
A Study to Determine the Value of 18F-FAZA PET Imaging in Patients With Breast Cancer
A Phase 2 study testing 18F-FAZA PET scan and FluGlucoScan Injection (18F-FDB) PET scan in people with Breast Neoplasm, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- 18F-FAZA PET scan and FluGlucoScan Injection (18F-FDB) PET scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 28 Nov 2008to 4 Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- 18F-FAZA PET scan, FluGlucoScan Injection (18F-FDB) PET scan
- Keywords
- 18F-FAZA, 18F-FDG, Positron Emission Tomography, Cell Hypoxia
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 18F-FAZA + FluGlucoScan Injection Receives: Drug: 18F-FAZA PET scan; Drug: FluGlucoScan Injection (18F-FDB) PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
General biodistribution of 18F-FAZA and FluGlucoScan Injection
Measured: 5 years
Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study start28 Nov 2008
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Why it stopped: Retirement of former Qualified Investigator and lack of resources to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel W Hudson, MD, Principal investigator, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771381
- Sponsor's protocol ID
- KT-FAZ-004
- Status last verified
- Feb 2019
- First submitted
- 19 Sep 2008
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pre-Treatment Hypoxia PET Imaging Study Using 18F-FAZA in Patients With Invasive Duct Carcinoma of the Breast
- ClinicalTrials.gov ID
- NCT00771381
- Acronym / sponsor ID
- KT-FAZ-004
- Conditions
- Breast Neoplasm
- Keywords
- 18F-FAZA, 18F-FDG, Positron Emission Tomography, Cell Hypoxia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Retirement of former Qualified Investigator and lack of resources to complete study
- Enrolment
- 23 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 28 Nov 2008 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 13 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 18F-FAZA PET scan, Drug: FluGlucoScan Injection (18F-FDB) PET scan18F-FAZA + FluGlucoScan Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FAZA PET scanRadioactive 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 | 1 |
| FluGlucoScan Injection (18F-FDB) PET scanRadioactive dose of 100-700 MBq per injection. A single pre-treatment injection of FluGlucoScan Injection and PET scan will be permitted per patient. | Drug | 1 |
Primary outcome
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
2 secondary outcomes
General biodistribution of 18F-FAZA and FluGlucoScan Injection
Time frame: 5 years
Comparison of pre-operative 18F-FAZA and FluGlucoScan Injection PET images
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Retirement of former Qualified Investigator and lack of resources to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel W Hudson, MD principal investigator
Cross Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-FAZA PET scan and FluGlucoScan Injection (18F-FDB) PET scan in people with Breast Neoplasm, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Retirement of former Qualified Investigator and lack of resources to complete study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.