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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Ruoh-Fang Yen, MD, PhD contact

886223123456 ext. 65581

rfyen@ntu.edu.tw

Taiwan1 site, 1 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

    Recruiting

Other trials in Taiwan

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:

  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. Use of dynamic and static PET to monitor treatment response for NAC, and to investigate the correlation of PET results versus MRS, DCE MRI.
  3. Compare clinical staging by PET/MR and by clinical assessment.
  4. 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:

  1. Use of PET-guided proton MRS and DCE MRI for patients who will receive NAC for breast cancer to monitor treatment response.
  2. Use of dynamic and static PET to monitor treatment response for NAC, and to investigate the correlation of PET results versus MRS, DCE MRI.
  3. Compare clinical staging by of PET/MR and by clinical assessment.
  4. 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 groups in NCT02766530
Study groupRoleWhat they receive
PETMR studyExperimentalAll 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.

  1. treatment effect of neoadjuvant chemotherapy evaluated by positron emission tomography magnetic resonance (PET/MR)

    Measured: 7 months for each patient

Secondary outcomes (1)
  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.

  1. First posted9 May 2016 (estimated)
  2. Study startJul 2014
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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)
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

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.

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