Locally Advanced Breast CancerPETLABNCT00788489
A Prospective Study to Evaluate FDG-PET, Breast MRI, and Breast Ultrasonography in Monitoring Tumour Responses in Patients With Locally Advanced Breast Cancer (LABC) Undergoing Neoadjuvant Chemotherapy
An observational study of Locally Advanced Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 1 site in Canada.
Trial summary
The overall goal of this study is to determine how FDG-PET, breast MRI and breast ultrasound can be incorporated into the assessment of treatment responses in women with LABC undergoing neoadjuvant chemotherapy. 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
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to Apr 2010
- Phase
- Observational
- 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
Study population: Approximately 100 patients will be accrued over a 5-year period.
Who may be able to join
- Histologic proof of breast cancer (invasive ductal or lobular carcinoma - not breast sarcoma or lymphoma)
- Patients having a clinical diagnosis of locally advanced breast cancer (T3 or T4, or N2 according to TNM classification) including inflammatory breast cancer.
- Patients must be able to undergo neoadjuvant chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 sufficient to undergo chemotherapy
Who cannot join
- Previously treated cancer other than nonmelanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater.
- Evidence of metastatic disease (found on chest X-ray, liver ultrasound or bone scan).
- Previous chemotherapy or hormonal therapy for breast cancer.
- Active infection or other significant illnesses which could hamper their ability to tolerate chemotherapy
- Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease) making the patient unfit for surgery.
- Any condition that could interfere with their ability to provide informed consent such as dementia or severe cognitive impairment.
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- Pregnant or lactating females (e.g. positive serum B-hCG pregnancy test).
- Unable to lie supine for imaging with PET.
- Inadequate hematologic, renal and liver function as measured by CBC (WBC < 4.0 x 109, Hb < 100 g/L, plt count < 100 x 109), and abnormal hepatic transaminases (AST, ALT, GGT, alkaline phosphatase > 2x normal), elevated total bilirubin, and elevated serum creatinine (Cr > 110 micromol/L).
- Any contraindication to undergoing MRI or PET.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Evaluate the Role of 2-[18F]Fluoro-2-deoxy-D-glucose (FDG)-Positron Emission Tomography (PET), Breast Magnetic Resonance Imaging (MRI), and Breast Ultrasonography in Monitoring Tumour Responses in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
The overall goal of this study is to determine how FDG-PET, breast MRI and breast ultrasound can be incorporated into the assessment of treatment responses in women with LABC undergoing neoadjuvant chemotherapy. A prospective cohort study will be conducted evaluating the ability of FDG-PET, breast MRI and breast ultrasound to detect the presence of residual tumour in patients with LABC who have completed treatment with neoadjuvant chemotherapy prior to mastectomy.
Read the detailed description
Locally advanced breast cancer (LABC) is usually treated with neoadjuvant chemotherapy followed by surgery and radiation. At present, monitoring of tumour responses to chemotherapy is primarily carried out using physical examination at the beginning of each chemotherapy cycle. Differentiating viable tumour tissue from inflammation or fibrotic scar tissue can be difficult. There is a growing body of evidence that newer imaging techniques such as positron emission tomography (PET) and magnetic resonance imaging (MRI) may be better at determining whether or not the tumour is actually shrinking. The purpose of this study is to determine the sensitivity and specificity of PET, MRI and ultrasound in evaluating tumour responses to chemotherapy in patients with LABC and compare this with physical examination, which is the current standard of care.
Two of the objectives of this study are to 1) determine whether PET, MRI or ultrasound have a higher sensitivity/specificity than physical examination alone in determining which LABC patients achieve a complete pathologic response following neoadjuvant chemotherapy, and 2) to investigate whether these additional investigations might lead to changes in clinical management by identifying non-responders earlier than with physical examination alone.
A prospective cohort study design will be conducted. Patients with LABC who receive chemotherapy will undergo physical examination, PET, MRI, and ultrasound at baseline, midway, and at the completion of chemotherapy. Approximately 100 patients will be accrued over a 5-year period.
This study will give clinicians further insight into the usefulness of PET, MRI, and ultrasound in monitoring treatment responses in patients with LABC. This could potentially lead to changes in clinical management of these patients.
- Conditions
- Locally Advanced Breast Cancer
- Keywords
- breast cancer, FDG-PET, MRI, chemotherapy, ultrasonography
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes are the sensitivity and specificity of physical examination, ultrasound, breast MRI and PET in predicting which patients have achieved a complete pathologic response (pCR) prior to undergoing surgery.
Measured: 5 years
Secondary outcomes (3)
Comparison of mean SUV uptake on FDG-PET for patients with pCR versus patients without pCR following neoadjuvant chemotherapy
Measured: 5 years
The size of the tumour measured by physical examination, breast ultrasound and MRI just prior to surgery will be compared to pathology tumour measurements found following mastectomy.
Measured: 5 years
Retrospective modelling to assess whether imaging test midway through chemotherapy affect management decisions
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 posted11 Nov 2008 (estimated)
- Study startJan 2006
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation
- Responsible party
- Sponsor
- Investigators
- Som Mukherjee, MD MSc FRCP(C), Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788489
- Sponsor's protocol ID
- PETLAB-06Jan2006
- Acronym
- PETLAB
- Status last verified
- Oct 2011
- First submitted
- 10 Nov 2008
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Role of 2-[18F]Fluoro-2-deoxy-D-glucose (FDG)-Positron Emission Tomography (PET), Breast Magnetic Resonance Imaging (MRI), and Breast Ultrasonography in Monitoring Tumour Responses in Patients With Locally Advanced Breast Cancer Undergoing Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT00788489
- Acronym / sponsor ID
- PETLAB / PETLAB-06Jan2006
- Conditions
- Locally Advanced Breast Cancer
- Keywords
- breast cancer, FDG-PET, MRI, chemotherapy, ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation
- Study start
- Jan 2006
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 11 Nov 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.
The overall goal of this study is to determine how FDG-PET, breast MRI and breast ultrasound can be incorporated into the assessment of treatment responses in women with LABC undergoing neoadjuvant chemotherapy. A prospective cohort study will be conducted evaluating the ability of FDG-PET, breast MRI and breast ultrasound to detect the presence of residual tumour in patients with LABC who have completed treatment with neoadjuvant chemotherapy prior to mastectomy.
Detailed description
Locally advanced breast cancer (LABC) is usually treated with neoadjuvant chemotherapy followed by surgery and radiation. At present, monitoring of tumour responses to chemotherapy is primarily carried out using physical examination at the beginning of each chemotherapy cycle. Differentiating viable tumour tissue from inflammation or fibrotic scar tissue can be difficult. There is a growing body of evidence that newer imaging techniques such as positron emission tomography (PET) and magnetic resonance imaging (MRI) may be better at determining whether or not the tumour is actually shrinking. The purpose of this study is to determine the sensitivity and specificity of PET, MRI and ultrasound in evaluating tumour responses to chemotherapy in patients with LABC and compare this with physical examination, which is the current standard of care.
Two of the objectives of this study are to 1) determine whether PET, MRI or ultrasound have a higher sensitivity/specificity than physical examination alone in determining which LABC patients achieve a complete pathologic response following neoadjuvant chemotherapy, and 2) to investigate whether these additional investigations might lead to changes in clinical management by identifying non-responders earlier than with physical examination alone.
A prospective cohort study design will be conducted. Patients with LABC who receive chemotherapy will undergo physical examination, PET, MRI, and ultrasound at baseline, midway, and at the completion of chemotherapy. Approximately 100 patients will be accrued over a 5-year period.
This study will give clinicians further insight into the usefulness of PET, MRI, and ultrasound in monitoring treatment responses in patients with LABC. This could potentially lead to changes in clinical management of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 100 patients will be accrued over a 5-year period.
Key inclusion criteria (4 listed)
- Histologic proof of breast cancer (invasive ductal or lobular carcinoma - not breast sarcoma or lymphoma)
- Patients having a clinical diagnosis of locally advanced breast cancer (T3 or T4, or N2 according to TNM classification) including inflammatory breast cancer.
- Patients must be able to undergo neoadjuvant chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 sufficient to undergo chemotherapy
Key exclusion criteria (10 listed)
- Previously treated cancer other than nonmelanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater.
- Evidence of metastatic disease (found on chest X-ray, liver ultrasound or bone scan).
- Previous chemotherapy or hormonal therapy for breast cancer.
- Active infection or other significant illnesses which could hamper their ability to tolerate chemotherapy
- Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac disease, severe chronic obstructive pulmonary disease) making the patient unfit for surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcomes are the sensitivity and specificity of physical examination, ultrasound, breast MRI and PET in predicting which patients have achieved a complete pathologic response (pCR) prior to undergoing surgery.
Time frame: 5 years
3 secondary outcomes
Comparison of mean SUV uptake on FDG-PET for patients with pCR versus patients without pCR following neoadjuvant chemotherapy
Time frame: 5 years
The size of the tumour measured by physical examination, breast ultrasound and MRI just prior to surgery will be compared to pathology tumour measurements found following mastectomy.
Time frame: 5 years
Retrospective modelling to assess whether imaging test midway through chemotherapy affect management decisions
Time frame: 5 years
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 4 Oct 2011.
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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, MD MSc FRCP(C) principal investigator
Juravinski Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Locally Advanced Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) 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 4 inclusion and 10 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 4 Oct 2011. 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.
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?
The primary outcomes are the sensitivity and specificity of physical examination, ultrasound, breast MRI and PET in predicting which patients have achieved a complete pathologic response (pCR) prior to undergoing surgery. (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 4 Oct 2011.