Breast CancerNCT01190566
PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer
An observational study of Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is: To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2010to May 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients who are candidates for neoadjuvant chemotherapy, pre-treatment MRI and PET scan, post-treatment MRI and PET scan for evaluation of chemotherapy response monitoring and residual disease
Who may be able to join
- Pathologically confirmed breast cancer
- Clinical stage IIb, IIIa, IIIb, IIIc
- Must have measurable disease
- Performance status of ECOG 0-2
- Adequate, bone marrow, liver, heart, and renal function
- Who did not receive chemotherapy for breast cancer
- Must agree with and signed informed consent
Who cannot join
- Prior history of cancer besides breast cancer
- Active bacterial infection
- Pregnant or lactating women
- Psychological disease or seizure
- History of arrhythmia, congestive heart failure, myocardial infarct, or unstable angina
- Male breast cancer
- Who had a pacemaker or history of open heart surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
The purpose of this study is:
To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
Read more
To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI, dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To compare the performances of dynamic contrast-enhanced MRI using parametric response map analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer patients
Read the detailed description
Enrolled women with breast cancers who had received an anthracycline-taxane regimen and subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor status, and surgery type) and imaging parameters were compared according to the pathological response.
- Conditions
- Breast Cancer
- Keywords
- Magnetic Resonance Imaging, Functional, Tomography, Positron-Emission, chemotherapy
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Patholocial Response to Chemotherapy
Pathological complete response (pCR) or non-pCR
Measured: Post-operation
Secondary outcomes (8)
Tumor Size
Maximal tumor diameter measured on magnetic resonance imaging
Measured: baseline, completion of 1st cycle of chemotherapy
Tumor Volume
Tumor volume measured on 3-dimensional magnetic resonance imaging
Measured: Baseline, post-1st chemotherapy
Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)
Parametric response map analysis using a software calculates the interval change of signal intensity based on a voxel-to-voxel comparison between measurements at baseline and after the first cycle of chemotherapy. PRMSI+ indicates proportions of voxels within a tumor with increased signal intensity. PRMSI- indicates proportions of voxels within a tumor with decreased signal intensity. PRMSI0 indicates proportions of voxels within a tumor with unchanged signal intensity.
Measured: Baseline, post-1st chemotherapy
Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)
Measured: Baseline, post-1st chemotherapy
Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)
Measured: Baseline, post-1st chemotherapy
Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)
Measured: Baseline, post-1st chemotherapy
Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy
Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.
Measured: Baseline, post-1st chemotherapy
Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography
Measured: Baseline, post-1st chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Woo Kyung Moon, Seoul National University Hospital
- Investigators
- Woo Kyung Moon, M.D., Ph.D., Principal investigator, Department of Radiology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190566
- Sponsor's protocol ID
- PET-MR Breast Cancer
- Status last verified
- Jun 2015
- First submitted
- 25 Aug 2010
- Last updated
- 7 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13.
PubMed 24738612
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01190566
- Acronym / sponsor ID
- PET-MR Breast Cancer
- Conditions
- Breast Cancer
- Keywords
- Magnetic Resonance Imaging, Functional, Tomography, Positron-Emission, chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- May 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Posted 7 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
To validate the efficacy of multiparametric MRI, FDG-PET, RGD-PET, and PET-MR fusion imaging in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To identify the optimal combination parameters of MR spectroscopy, diffusion-weighted MRI, dynamic contrast-enhanced MRI, FDG-PET, and RGD-PET in the prediction and monitoring response to neoadjuvant chemotherapy of locally advanced breast cancer patients.
To compare the performances of dynamic contrast-enhanced MRI using parametric response map analysis versus those of pharmacokinetic parameters (Ktrans, kep, or Ve) in the early prediction of pathological responsiveness to neoadjuvant chemotherapy in breast cancer patients
Detailed description
Enrolled women with breast cancers who had received an anthracycline-taxane regimen and subsequent surgery were prospectively enrolled. DCE-MRI and FDG-PET scan were performed before and after the 1st cycle of chemotherapy. MR imaging parameters and SUV on PET scan within a tumor were analyzed. Clinicopathologic (age, clinical tumor stage, hormonal receptor status, and surgery type) and imaging parameters were compared according to the pathological response.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who are candidates for neoadjuvant chemotherapy, pre-treatment MRI and PET scan, post-treatment MRI and PET scan for evaluation of chemotherapy response monitoring and residual disease
Key inclusion criteria (7 listed)
- Pathologically confirmed breast cancer
- Clinical stage IIb, IIIa, IIIb, IIIc
- Must have measurable disease
- Performance status of ECOG 0-2
- Adequate, bone marrow, liver, heart, and renal function
Key exclusion criteria (7 listed)
- Prior history of cancer besides breast cancer
- Active bacterial infection
- Pregnant or lactating women
- Psychological disease or seizure
- History of arrhythmia, congestive heart failure, myocardial infarct, or unstable angina
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
Patholocial Response to Chemotherapy
Time frame: Post-operation
Pathological complete response (pCR) or non-pCR
8 secondary outcomes
Tumor Size
Time frame: baseline, completion of 1st cycle of chemotherapy
Tumor Volume
Time frame: Baseline, post-1st chemotherapy
Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)
Time frame: Baseline, post-1st chemotherapy
Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)
Time frame: Baseline, post-1st chemotherapy
Rate Constant of the Escape of the Contrast Agent From the Extracellular Extravascular Space Into the Plasma Compartment (Kep)
Time frame: Baseline, post-1st chemotherapy
Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)
Time frame: Baseline, post-1st chemotherapy
Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy
Time frame: Baseline, post-1st chemotherapy
Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography
Time frame: Baseline, post-1st chemotherapy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24738612Cho N, Im SA, Park IA, Lee KH, Li M, Han W, Noh DY, Moon WK. Breast cancer: early prediction of response to neoadjuvant chemotherapy using parametric response maps for MR imaging. Radiology. 2014 Aug;272(2):385-96. doi: 10.1148/radiol.14131332. Epub 2014 Apr 13.
- Homepage of Seoul National University Hospital Biomedical Research InstituteLink provided by the sponsor.
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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.
Woo Kyung Moon, M.D., Ph.D. principal investigator
Department of Radiology, Seoul National University Hospital
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 Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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 7 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 7 Jul 2015. 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 South Korea. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patholocial Response to Chemotherapy (time frame: Post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01190566, which also lists 1 linked publication.
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 7 Jul 2015.