PET/MR Radiomics for Breast Cancer Diagnosis

NCT05466760 | Unknown

• 1 other identifier: 2017-03-002A
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast cancer; radiomics; hybrid PET/MRI

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of PET/MR imaging metrics in prediction of treatment response to chemotherapy

  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 Outcomes (3)

• Comparison of PET/MR imaging metrics among patients with different histologic grades

  2 weeks

• Comparison of PET/MR imaging metrics among patients with different molecular subtypes.

  2 weeks

• Performance of PET/MR imaging metrics to predict the recurrence status.

  5 years

Study Arms (2)

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

Interventions

PET/MR RADIATION

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.

Patients with recently diagnosed breast cancer who will undergo NAC.

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \. 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.
• \. 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.
• \. Past history of claustrophobia.
• \. Women who are pregnant or who are planning to be pregnant, or who are lactating
• \. Past history of breast cancer within recent 5 years
• \. Women undergoing chemotherapy for other disease entity in recent 1 year.
• \. Women who cannot cooperate with the examinations.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Department of Radiology,Taipei Veterans General Hospital

Taipei, 112304, Taiwan

RECRUITING

Related Publications (15)

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  PMID: 26835491 BACKGROUND

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Jane Wang, PhD

  Department of Radiology,Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Wang, PhD

CONTACT

+886-2-28712121; jwang2@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 40 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: July 20, 2022
• Study Start: July 6, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)