Breast CancerPhase 4NCT02766530
Integrated Positron Emission Tomography Magnetic Resonance (PET/MR) of Breast Cancer
A Phase 4 study testing PETMR study in people with Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators will use integrated PET/MR for the goals below: 1. Use of PET-guided proton MRS (MR spectroscopy) and DCE MRI (dynamic contrast-enhanced MRI) for patients who will receive NAC (neoadjuvant chemotherapy) for breast cancer to monitor treatment response. 2. Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PETMR study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2014to Dec 2018
- Phase
- Phase 4
- 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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 25-75 years old.
- Women with recently diagnosed breast cancer and who will receive NAC to reduce tumor burden before surgery. (including locally advanced breast cancer (LABC) according to clinical assessment; or tumor size > 2cm, that is, at least T2 in TNM staging).
Who cannot join
- Estimated GFR (eGFR) < 60 mL/min/1.73 m2 and blood glucose > 135 mg/dl; Past or present history of acute renal failure, renal dialysis, diabetes mellitus.
- Women who received metallic fixation, coronary artery stent in recent 3 months; or women who received mechanical valve replacement that is not compatible with MR magnet; or women with aneurysmal clips, pacemakers.
- Past history of claustrophobia.
- Women who are pregnant or who are planning to be pregnant, or who are lactating (though the possibility in our target population should be very low)
- Past history of breast cancer within recent 5 years before the currently diagnosed breast cancer.
- Women who received chemotherapy for other disease entity in recent 1 year.
- Women who cannot cooperate with the examinations.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Ruoh-Fang Yen, MD, PhD, 886223123456 ext. 65581, rfyen@ntu.edu.tw
Jane Wang, MD, PhD, 886228712121 ext. 2979, jwwangjen@gmail.com
About this study
Official title: Use of Integrated PET/MR to Evaluate Clinical Staging and Monitor Treatment Response of Neoadjuvant Chemotherapy for Breast Cancer Patients: A Pilot Study
The investigators will use integrated PET/MR for the goals below:
- Use of PET-guided proton MRS (MR spectroscopy) and DCE MRI (dynamic contrast-enhanced MRI) for patients who will receive NAC (neoadjuvant chemotherapy) for breast cancer to monitor treatment response.
- Use of dynamic and static PET to monitor treatment response for NAC, and to investigate the correlation of PET results versus MRS, DCE MRI.
- Compare clinical staging by PET/MR and by clinical assessment.
- On pre-chemotherapy studies, to investigate the association of molecular marker status with the dynamic and static PET, MRS and DCE MRI parameters.
Read the detailed description
Breast MRI with dynamic contrast-enhanced series (DCE MRI) is sensitive for breast cancer diagnosis (sensitivity 95-100%) with variable specificity (37-97%). Breast MRI was also used for pre-operative staging, and monitoring of therapeutic response of neoadjuvant chemotherapy (NAC). DCE MRI analysis with semi-quantitative and pharmacokinetic method can discriminate the responders versus non-responders during NAC. Analysis of choline peak on proton MR spectroscopy (MRS) can increase the MRI specificity of breast lesion diagnosis to 82-100%. Choline analysis was also used for monitoring treatment response of NAC. The change of choline integral can parallel the response status of NAC and was well correlated (r=0.91; P=0.01) with the change of lesion size, and the choline change can be found as early as 24 hours after first dose of chemotherapy.
Breast Positron Emission Tomography (PET) with 18F-FDG (2-deoxy-2-(18F)fluoro-D-glucose) was mainly used for staging and monitoring of treatment response of NAC, with the reduction of FDG uptake (P<0.001) was more evident than that of tumor size (P=0.005). However, FDG PET displayed a limited role in evaluation of primary breast cancer, brain and axillary lymph nodes metastases. There were publications regarding combined FDG PET/CT and breast MRI for breast cancer diagnosis and monitoring NAC response. The SUV on static PET and MRI findings were correlated well with molecular marker status of breast cancer (ER, PR, HER2), and were associated with clinical outcome. The change of choline integral on MRS was well correlated to the peak of SUV during NAC (r=0.84,P=0.02).The changes of dynamic PET parameters including rate constants for uptake, washout and FDG influx were moderately correlated with the DCE MRI parameters and can reflect the response status of NAC. However, PET/CT and MRI were performed by two machines at different time, so breast positioning is different, causing the lesion targeting sometimes difficult. Moreover, the selection of ROI/VOI for PET and MRS, DCE MRI is subjective with inter-observer bias. A new technology- PET/MR- can solve these problems. PET/MR has less radiation and offers more soft tissue details than PET/CT. A most recent PET/MR design- integrated PET/MR- is commercially available. Using the integrated PET/MR, patients can undergo whole body PET and MRI at the same time, followed by dedicated protocol for specific organ of primary tumor origin. The ROI/VOI of breast DCE MRI, MRS can be selected according to SUVmax site from PET, which is more objective and can ensure that the VOI/ROI is at same location across all techniques. PET/MR showed comparable reliability to PET/CT for detection of oncologic diseases, and contributed even more changes of clinical management than PET/CT. However, use of PET/MR for breast cancer was seldom reported.
The investigators will use integrated PET/MR for the studies below:
- Use of PET-guided proton MRS and DCE MRI for patients who will receive NAC for breast cancer to monitor treatment response.
- Use of dynamic and static PET to monitor treatment response for NAC, and to investigate the correlation of PET results versus MRS, DCE MRI.
- Compare clinical staging by of PET/MR and by clinical assessment.
- On pre-chemotherapy studies, to investigate the association of molecular marker status with the dynamic and static PET, MRS and DCE MRI parameters.
- Conditions
- Breast Cancer
- Being tested
- PETMR study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PETMR studyOther
Also called MRI PET
Use of PETMR study to evaluate the treatment response of breast cancer women
| Study group | Role | What they receive |
|---|---|---|
| PETMR study | Experimental | All the study participants will receive PET MR examinations before neoadjuvant chemotherapy and during neoadjuvant chemotherapy (during early cycle as well as during mid-cycle of chemotherapy treatment). There will be two groups of patients after completion of neoadjuvant chemotherapy, that is, responders versus non-responders. We will compare the PET MR imaging parameters before, during neoadjuvant chemotherapy between the two groups of patients. Receives: Other: PETMR study |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment effect of neoadjuvant chemotherapy evaluated by positron emission tomography magnetic resonance (PET/MR)
Measured: 7 months for each patient
Secondary outcomes (1)
Clinical staging of pre-chemotherapy breast cancer by PET/MR
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startJul 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruoh-Fang Yen, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766530
- Sponsor's protocol ID
- 201401091MINA
- Status last verified
- May 2016
- First submitted
- 23 Apr 2016
- Last updated
- 9 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Integrated PET/MR to Evaluate Clinical Staging and Monitor Treatment Response of Neoadjuvant Chemotherapy for Breast Cancer Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT02766530
- Acronym / sponsor ID
- 201401091MINA
- Conditions
- Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 May 2016 (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 investigators will use integrated PET/MR for the goals below:
- Use of PET-guided proton MRS (MR spectroscopy) and DCE MRI (dynamic contrast-enhanced MRI) for patients who will receive NAC (neoadjuvant chemotherapy) for breast cancer to monitor treatment response.
- Use of dynamic and static PET to monitor treatment response for NAC, and to investigate the correlation of PET results versus MRS, DCE MRI.
- Compare clinical staging by PET/MR and by clinical assessment.
- On pre-chemotherapy studies, to investigate the association of molecular marker status with the dynamic and static PET, MRS and DCE MRI parameters.
Detailed description
Breast MRI with dynamic contrast-enhanced series (DCE MRI) is sensitive for breast cancer diagnosis (sensitivity 95-100%) with variable specificity (37-97%). Breast MRI was also used for pre-operative staging, and monitoring of therapeutic response of neoadjuvant chemotherapy (NAC). DCE MRI analysis with semi-quantitative and pharmacokinetic method can discriminate the responders versus non-responders during NAC. Analysis of choline peak on proton MR spectroscopy (MRS) can increase the MRI specificity of breast lesion diagnosis to 82-100%. Choline analysis was also used for monitoring treatment response of NAC. The change of choline integral can parallel the response status of NAC and was well correlated (r=0.91; P=0.01) with the change of lesion size, and the choline change can be found as early as 24 hours after first dose of chemotherapy.
Breast Positron Emission Tomography (PET) with 18F-FDG (2-deoxy-2-(18F)fluoro-D-glucose) was mainly used for staging and monitoring of treatment response of NAC, with the reduction of FDG uptake (P<0.001) was more evident than that of tumor size (P=0.005). However, FDG PET displayed a limited role in evaluation of primary breast cancer, brain and axillary lymph nodes metastases. There were publications regarding combined FDG PET/CT and breast MRI for breast cancer diagnosis and monitoring NAC response. The SUV on static PET and MRI findings were correlated well with molecular marker status of breast cancer (ER, PR, HER2), and were associated with clinical outcome. The change of choline integral on MRS was well correlated to the peak of SUV during NAC (r=0.84,P=0.02).The changes of dynamic PET parameters including rate constants for uptake, washout and FDG influx were moderately correlated with the DCE MRI parameters and can reflect the response status of NAC. However, PET/CT and MRI were performed by two machines at different time, so breast positioning is different, causing the lesion targeting sometimes difficult. Moreover, the selection of ROI/VOI for PET and MRS, DCE MRI is subjective with inter-observer bias. A new technology- PET/MR- can solve these problems. PET/MR has less radiation and offers more soft tissue details than PET/CT. A most recent PET/MR design- integrated PET/MR- is commercially available. Using the integrated PET/MR, patients can undergo whole body PET and MRI at the same time, followed by dedicated protocol for specific organ of primary tumor origin. The ROI/VOI of breast DCE MRI, MRS can be selected according to SUVmax site from PET, which is more objective and can ensure that the VOI/ROI is at same location across all techniques. PET/MR showed comparable reliability to PET/CT for detection of oncologic diseases, and contributed even more changes of clinical management than PET/CT. However, use of PET/MR for breast cancer was seldom reported.
The investigators will use integrated PET/MR for the studies below:
- Use of PET-guided proton MRS and DCE MRI for patients who will receive NAC for breast cancer to monitor treatment response.
- Use of dynamic and static PET to monitor treatment response for NAC, and to investigate the correlation of PET results versus MRS, DCE MRI.
- Compare clinical staging by of PET/MR and by clinical assessment.
- On pre-chemotherapy studies, to investigate the association of molecular marker status with the dynamic and static PET, MRS and DCE MRI parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PETMR study | Experimental | Other: PETMR studyAll the study participants will receive PET MR examinations before neoadjuvant chemotherapy and during neoadjuvant chemotherapy (during early cycle as well as during mid-cycle of chemotherapy treatment). There will be two groups of patients after completion of neoadjuvant chemotherapy, that is, responders versus non-responders. We will compare the PET MR imaging parameters before, during neoadjuvant chemotherapy between the two groups of patients. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged 25-75 years old.
- Women with recently diagnosed breast cancer and who will receive NAC to reduce tumor burden before surgery. (including locally advanced breast cancer (LABC) according to clinical assessment; or tumor size > 2cm, that is, at least T2 in TNM staging).
Key exclusion criteria (7 listed)
- Estimated GFR (eGFR) < 60 mL/min/1.73 m2 and blood glucose > 135 mg/dl; Past or present history of acute renal failure, renal dialysis, diabetes mellitus.
- Women who received metallic fixation, coronary artery stent in recent 3 months; or women who received mechanical valve replacement that is not compatible with MR magnet; or women with aneurysmal clips, pacemakers.
- Past history of claustrophobia.
- Women who are pregnant or who are planning to be pregnant, or who are lactating (though the possibility in our target population should be very low)
- Past history of breast cancer within recent 5 years before the currently diagnosed breast cancer.
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 |
|---|---|---|
| PETMR studyAlso: MRI PETUse of PETMR study to evaluate the treatment response of breast cancer women | Other | PETMR study |
Primary outcome
treatment effect of neoadjuvant chemotherapy evaluated by positron emission tomography magnetic resonance (PET/MR)
Time frame: 7 months for each patient
1 secondary outcome
Clinical staging of pre-chemotherapy breast cancer by PET/MR
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- Individual participant dataSharing planned: Undecided. undecided yet
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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.
Ruoh-Fang Yen, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PETMR study in people with Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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: status not confirmed, as of the sponsor's last update on 9 May 2016. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruoh-Fang Yen, MD, PhD (886223123456 ext. 65581, rfyen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment effect of neoadjuvant chemotherapy evaluated by positron emission tomography magnetic resonance (PET/MR) (time frame: 7 months for each patient). 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 9 May 2016.