Locally Advanced Breast Cancer (LABC)IMPACTNCT01240681
Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
A study testing FLT PET and BOLD MRI scan in people with Locally Advanced Breast Cancer (LABC), run by Ontario Clinical Oncology Group (OCOG) at 4 sites in Canada.
Trial summary
The objective of this pilot study is to determine the effectiveness of Fluorothymidine Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women with locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Breast Cancer (LABC)
- What is being tested?
- FLT PET and BOLD MRI scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesCanada
- Study dates
- Apr 2011to Jan 2015
- Phase
- Interventional
- 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
- Histologic proof of breast cancer (invasive ductal or lobular carcinoma). Breast sarcoma and lymphoma are not eligible.
- Clinical diagnosis of locally advanced breast cancer (Stage IIB (T3,N0,M0), Stage IIIA, IIIB, or IIIC, according to American Joint Committee on Cancer (AJCC) Tumour-Node-Metastasis (TNM) Cancer Staging), including inflammatory breast cancer.
- Ability to undergo neoadjuvant chemotherapy.
Who cannot join
- Evidence of metastatic disease (identified on chest x-ray, liver ultrasound, bone scan or other imaging tests);
- Previous chemotherapy or hormonal therapy for breast cancer;
- Significant concurrent medical problems that result in the patient being unfit for surgery (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease);
- Known pregnancy or lactating female (e.g. positive serum beta human chorionic gonadotropin (B-hCG) pregnancy test);
- Inability to lie supine for imaging with Positron Emission Tomography (PET);
- Any contraindication to undergoing Magnetic Resonance Imaging (MRI) or PET;
- Currently receiving Antabuse;
- Inability to provide informed consent (e.g. dementia or severe cognitive impairment).
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Juravinski Cancer Centre
Hamilton, Ontario, L8V5C2
London Health Sciences Centres - London Regional Cancer Program
London, Ontario
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B6V4
Sunnybrook Odette Health Sciences Centre
Toronto, Ontario, M4N3M5
About this study
Official title: A Pilot Study of Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
The objective of this pilot study is to determine the effectiveness of Fluorothymidine Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women with locally advanced breast cancer.
- Conditions
- Locally Advanced Breast Cancer (LABC)
- Being tested
- FLT PET and BOLD MRI scan
- Keywords
- Locally Advanced Breast Cancer (LABC), neoadjuvant chemotherapy, Fluorothymidine Positron Emission Tomography (FLT PET), Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI), tumor response, mastectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLT PET and BOLD MRI scanProcedure or surgery
Eligible consenting patients with LABC receiving neoadjuvant chemotherapy (NA CT) will undergo FLT PET, BOLD MRI, and clinical examination of the involved breast including ipsilateral axillary and supraclavicular nodes to assess the treatment response to chemotherapy (CT). The imaging studies will be performed at baseline and after the first cycle of NA CT.
| Study group | Role | What they receive |
|---|---|---|
| FLT PET and BOLD MRI scan | Other | All subjects will have the study intervention of FLT PET and BOLD MRI at baseline and after the first cycle of chemotherapy Receives: Procedure: FLT PET and BOLD MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response (partial and complete)
Partial clinical response refers to at least a 50% reduction in the dimensions of the tumour mass and a complete clinical response refers to complete absence of the mass on physical exam, as well as absence of inflammation, ulceration and peau d'orange.
Measured: 6 months (approximately)
Secondary outcomes (2)
Pathologic response
Using the Residual Cancer Burden (RCB) index the pathologic response will be divided into categories. The three categories are complete response, near complete response and chemotherapy resistance. A complete pathologic response (pCR) refers to complete absence of invasive cancer.
Measured: 6 months (approximately)
Imaging Quantification
Fluorothymidine Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent (BOLD) MRI quantification of tumor responses to predict which patients are likely to achieve a pathologic complete response.
Measured: 6 months (approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast Cancer (LABC)Studies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Som Mukherjee, Principal investigator, Juravinski Cancer Centre Hamilton, Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240681
- Sponsor's protocol ID
- OCOG-2010-IMPACT
- Acronym
- IMPACT
- Status last verified
- Mar 2015
- First submitted
- 1 Nov 2010
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) and Fluorothymidine Positron Emission Tomography (FLT PET) in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01240681
- Acronym / sponsor ID
- IMPACT / OCOG-2010-IMPACT
- Conditions
- Locally Advanced Breast Cancer (LABC)
- Keywords
- Locally Advanced Breast Cancer (LABC), neoadjuvant chemotherapy, Fluorothymidine Positron Emission Tomography (FLT PET), Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI), tumor response, mastectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Nov 2010 (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.
The objective of this pilot study is to determine the effectiveness of Fluorothymidine Positron Emission Tomography (FLT PET) and Blood Oxygen Level Dependent Magnetic Resonance Imaging (BOLD MRI) in assessing tumour response to neoadjuvant chemotherapy (NA CT) in women with locally advanced breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLT PET and BOLD MRI scan | Other | Procedure: FLT PET and BOLD MRI scanAll subjects will have the study intervention of FLT PET and BOLD MRI at baseline and after the first cycle of chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Histologic proof of breast cancer (invasive ductal or lobular carcinoma). Breast sarcoma and lymphoma are not eligible.
- Clinical diagnosis of locally advanced breast cancer (Stage IIB (T3,N0,M0), Stage IIIA, IIIB, or IIIC, according to American Joint Committee on Cancer (AJCC) Tumour-Node-Metastasis (TNM) Cancer Staging), including inflammatory breast cancer.
- Ability to undergo neoadjuvant chemotherapy.
Key exclusion criteria (8 listed)
- Evidence of metastatic disease (identified on chest x-ray, liver ultrasound, bone scan or other imaging tests);
- Previous chemotherapy or hormonal therapy for breast cancer;
- Significant concurrent medical problems that result in the patient being unfit for surgery (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease);
- Known pregnancy or lactating female (e.g. positive serum beta human chorionic gonadotropin (B-hCG) pregnancy test);
- Inability to lie supine for imaging with Positron Emission Tomography (PET);
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 |
|---|---|---|
| FLT PET and BOLD MRI scanEligible consenting patients with LABC receiving neoadjuvant chemotherapy (NA CT) will undergo FLT PET, BOLD MRI, and clinical examination of the involved breast including ipsilateral axillary and supraclavicular nodes to assess the treatment response to chemotherapy (CT). The imaging studies will be performed at baseline and after the first cycle of NA CT. | Procedure or surgery | FLT PET and BOLD MRI scan |
Primary outcome
Clinical response (partial and complete)
Time frame: 6 months (approximately)
Partial clinical response refers to at least a 50% reduction in the dimensions of the tumour mass and a complete clinical response refers to complete absence of the mass on physical exam, as well as absence of inflammation, ulceration and peau d'orange.
2 secondary outcomes
Pathologic response
Time frame: 6 months (approximately)
Imaging Quantification
Time frame: 6 months (approximately)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
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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.
Som Mukherjee principal investigator
Juravinski Cancer Centre Hamilton, Ontario
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLT PET and BOLD MRI scan in people with Locally Advanced Breast Cancer (LABC), run by Ontario Clinical Oncology Group (OCOG) at 4 sites 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical response (partial and complete) (time frame: 6 months (approximately)). 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 11 Mar 2015.