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NCT Number: NCT01190566

PET-MR for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Patholocial Response to Chemotherapy

    Time frame: Post-operation

    Pathological complete response (pCR) or non-pCR

Secondary outcomes

  1. Tumor Size

    Time frame: baseline, completion of 1st cycle of chemotherapy

    Maximal tumor diameter measured on magnetic resonance imaging

  2. Tumor Volume

    Time frame: Baseline, post-1st chemotherapy

    Tumor volume measured on 3-dimensional magnetic resonance imaging

  3. Proportions of Voxels Within a Tumor With Increased or Decreased Signal Intensity (Parametric Response Map Signal Intensity; PRMSI)

    Time frame: Baseline, post-1st chemotherapy

    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.

  4. Constant for the Transfer of the Contrast Agent From the Plasma Compartment Into the Extracellular Extravascular Space (Ktrans)

    Time frame: Baseline, post-1st chemotherapy

  5. 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

  6. Extracellular Extravascular Space Per Unit Volume of Tissue (Ve)

    Time frame: Baseline, post-1st chemotherapy

  7. Total Choline Amount of the Tumor Measured on Single Voxel 1H-magnetic Resonance Spectroscopy

    Time frame: Baseline, post-1st chemotherapy

    Single voxel 1H-magnetic resonance spectroscopy quantifies the amount of total choline-containing compounds of a tumor, which indicates cellular proliferation and malignant transformation.

  8. Standardized Uptake Value on 18F-fluoro-deoxy-glucose Positron Emission Tomography

    Time frame: Baseline, post-1st chemotherapy

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Official study title

PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 27, 2010
Registry last updated
Jul 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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