PET/MR Radiomics for Breast Cancer Diagnosis

July 18, 2022 updated by: Taipei Veterans General Hospital, Taiwan

Use of PET/MR Radiomics to Evaluate the Clinical Phenotypes, Response Status of Neoadjuvant Chemotherapy and Long-term Prognosis of Breast Cancer: a Preliminary Study

Breast cancer is the most common malignancy in women in our country (2013 cancer registry report, Health Promotion Administration). MRI is a more accurate imaging modality for breast lesion diagnosis, monitoring of treatment response, and local staging than compared with mammography and ultrasound. ¹⁸ F-FDG PET was reported to be used for breast cancer diagnosis, staging, and prediction of treatment response as well. We usually interpret the aforementioned imaging modalities by qualitative methods for decision-making. Radiomics is a process involving the conversion of images to quantitative data for subsequent data mining to improve decisional making for patient care, to adjust the patient management, that is so-called precision medicine. Our study is to use semantic and agnostic features of radiomics by hybrid PET/MR for 1. The pre-operative breast cancer patients (without neoadjuvant chemotherapy before operation). 2. The patients will receive neoadjuvant chemotherapy (NAC). The study intends to investigate the association of PET/MR radiomics data with the probability of metastasis or risk of recurrences and survival. We will also investigate if the BD and BPE (measured on MRI) are associated with molecular subtypes, histologic grade and clinical outcome, risk of metastases, and long-term survival of breast cancer patients for the study participants.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Purposes and background introduction:

Breast cancer is the most common malignancy in women in our country (2013 cancer registry report, Health Promotion Administration). MRI is a more accurate imaging modality for breast lesion diagnosis, monitoring of treatment response, and local staging than compared with mammography and ultrasound. ¹⁸ F-FDG PET was reported to be used for breast cancer diagnosis, staging, and prediction of treatment response as well. We usually interpret the aforementioned imaging modalities by qualitative methods for decision-making. In recent years, the concept of "Radiomics" is emerging. Radiomics is a process involving the conversion of images (imaging phenotypes) to quantitative data for subsequent data mining to improve decisional making for patient care, to adjust the patient management, that is so-called precision medicine. Radiomics is applied for the diagnostic, prognostic, and predictive purposes of diseases. There are two main approaches to radiomics: First, the semantic approach, which uses the usual radiological lexicon derived from regions of interest; second, the agnostic approach is higher-order, mathematically computed data derived from images instead of the commonly used radiologists' lexicon. MRI and PET can be used in breast radiomics studies. Hybrid PET/MR is a machine that the PET and MRI can be performed on the same table at the same time slot, therefore, the imaging data of MRI and PET can be obtained at the same examination, with less radiation dosage, more reliable lesion mapping than separate examinations of PET/CT and MRI.

Material and methods:

There is a total of 120 patients would like to be included in the study. Our study is to use semantic and agnostic features of radiomics by hybrid PET/MR for:

  1. The pre-operative breast cancer patients (without neoadjuvant chemotherapy before operation): to investigate the association of PET/MR imaging data with molecular subtypes, cell proliferation (Ki-67), tumor aggressiveness (by histologic grade).
  2. The patients who will receive neoadjuvant chemotherapy (NAC): PET/MR study will be performed for 3 times: pre-MAC (study 1), PET/MR after 1st dose of NAC (study 2), and PET/MR after 3rd or 4th NAC (study 3). We will investigate the predictive ability of PET/MR imaging data for NAC response. And we will investigate which parameters at which series of examinations are more predictive of the final NAC response. Therefore, we can adjust the NAC regimen as early as possible.
  3. The breast cancer patients mentioned above: we will investigate the association of PET/MR radiomics data with the probability of metastasis or risk of recurrences and survival.
  4. We will also investigate if the BD and BPE (measured on MRI) are associated with molecular subtypes, histologic grade and clinical outcome, risk of metastases, and long-term survival of breast cancer patients for the study participants.

Data analysis:

  1. For the breast cancer patients who will go directly to surgical treatment: We will analyze the association of MRI and PET semantic radiomics features (including DCE MRI, DWI/ADC, CEST, MRS and SUVmax, MTV, TLG) and agnostic radiomics ( texture) features with molecular subtypes, proliferation index (Ki-67), histology type and grades, and tumor size, lymph node status. And we will also investigate whether the semantic or agnostic/ texture analysis, or combination of both can be predictive of the factors associated with clinical outcome (that is, molecular subtype, Ki-67, histology type and grade, size, LN status).

  2. For the patients who will receive NAC: As stated previously, each participant is designed to undergo three examinations:

    Study 1- pre-NAC PET/MR; Study 2- first follow-up PET/MR is performed after first dose of NAC; Study 3, second follow-up PET/MR is performed after third or fourth dose of the NAC. The NAC protocol is mainly antracycline-based followed by taxane-based regimen for a total of 6- 8 cycles.

  3. For long-term follow-up:The 5-year survival of each study participant will be obtained, and we will investigate the association of all aforementioned PET or MRI-related radiomics parameters with overall survival, disease-free survival by Cox proportional hazards model. Kaplan-Meier analysis for survival curves and comparison of survival by log-rank test will also be estimated.
  4. The association of BPE and breast density (BD) with long term outcome:
  5. The Statistical analysis will be performed by Stata 13 (Stata Corp., College Station, Texas, USA) and SAS 9.3 (SAS Institute Inc., Cary, NC, USA). A P value <0.05 will be regarded as statistical significance.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 112304
        • Recruiting
        • Department of Radiology,Taipei Veterans General Hospital
        • Contact:
        • Sub-Investigator:
          • Ling-Ming Tseng, MD
        • Sub-Investigator:
          • Ko-Han Lin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

We will recruit two types of study participants in our study:

  1. Patients with recently diagnosed breast cancer who will undergo surgery (without NAC, but may undergo postoperative adjuvant chemotherapy and other regimens after surgery)
  2. Patients with recently diagnosed breast cancer who will undergo NAC.

Description

Inclusion Criteria:

  • 1. Women aged 25-75 years old.
  • 2. Women with recently diagnosed breast cancer.

Exclusion Criteria:

  • 1. Estimated GFR (eGFR) < 60 mL/min/1.73 m2 and blood glucose > 135 mg/dl; Past/ present history of acute renal failure, renal dialysis, DM.
  • 2. Women with metallic fixation, coronary artery stent in recent 3 months; or women with mechanical valve replacement not compatible with MR magnet; or women with aneurysmal clips, pacemakers.
  • 3. Past history of claustrophobia.
  • 4. Women who are pregnant or who are planning to be pregnant, or who are lactating
  • 5. Past history of breast cancer within recent 5 years
  • 6. Women undergoing chemotherapy for other disease entity in recent 1 year.
  • 7. Women who cannot cooperate with the examinations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient recently diagnosed breast cancer who will undergo surgery
surgery treatment only
Patients with recently diagnosed breast cancer who will undergo NAC.
Patients with recently diagnosed breast cancer who will undergo NAC before surgery.
Radiation: PET/MR
Study 1- pre-NAC PET/MR; Study 2- first follow-up PET/MR is performed after first dose of NAC; Study 3, second follow-up PET/MR is performed after third or fourth dose of the NAC. The NAC protocol is mainly antracycline-based followed by taxane-based regimen for a total of 6-8 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of PET/MR imaging metrics in prediction of treatment response to chemotherapy
Time Frame: 40 weeks
Determination of the sensitivity, specificity of PET/MR imaging metrics to predict treatment response to neoadjuvant chemotherapy. The treatment response will be determined by RCB (residual cancer burden) index at surgical pathology after completion of neoadjuvant chemotherapy and further categorized as group 1: RCB 0 or I; group 2: RCB II or III. The logistic regression will be performed with the groups (1 or 2) as dependent variable and the different PET/MR imaging metrics as independent variables, the ROC analysis and sensitivity, specificity of the PET/MR imaging metrics will be inferred from the regression models.
40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of PET/MR imaging metrics among patients with different histologic grades
Time Frame: 2 weeks
The histologic grades will be categorized as grade I, II, III. The difference of PET/MR imaging metrics among patients of non-high grade (grades I, II) and high grade (grade III) will be compared by Mann-Whitney U test.
2 weeks
Comparison of PET/MR imaging metrics among patients with different molecular subtypes.
Time Frame: 2 weeks
The molecular subtypes will be categorized as luminal, HER2-enriched, triple negative breast cancers (TNBC). The difference of PET/MR imaging metrics among patients of different subtypes will be compared by Kruskal-Wallis test.
2 weeks
Performance of PET/MR imaging metrics to predict the recurrence status.
Time Frame: 5 years
Determination of the of PET/MR imaging metrics to predict recurrence status at 5 years after breast cancer diagnosis. The Cox proportional hazards regression model will be performed with the recurrence status (recurrence or not) as dependent variable and the different PET/MR imaging metrics as independent variables, the hazards ratios from the different PET/MR imaging metrics estimated from the models will be compared.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Jane Wang, PhD, Department of Radiology,Taipei Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2018

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (ACTUAL)

July 20, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 18, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-03-002A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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