Imaging Breast Cancer with Fluorocholine PETMR to Predict Tumor Types and Outcomes
A Study on Women Aged 25 to 75 Receiving Chemotherapy or Surgery
Led by Taipei Veterans General Hospital, Taiwan · Updated on 2026-07-06
195
Participants Needed
1
Research Sites
82 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to explore the use of pre-treatment Fluorocholine FCH PETMR imaging in women diagnosed with breast cancer. The study evaluates whether conventional PETMR imaging markers and advanced radiomic features, including deep learning analysis, are associated with different molecular subtypes of breast cancer, treatment response, clinical outcomes, and survival. The goal is to identify which imaging parameters are most accurate for predicting these factors.
Participants will undergo two main imaging procedures before treatment whole-body PETMR using Fluorodeoxyglucose FDG and breast PETMR using Fluorocholine FCH. The whole-body PETMR follows a fasting period and involves an intravenous injection of FDG, followed by a 20-25 minute scan. The breast PETMR also requires fasting, an intravenous injection of FCH, a rest period, and then a 30-35 minute scan with MRI contrast media. These imaging tests occur on separate days with at least a two-day gap. Radiologists and nuclear medicine physicians analyze the results to provide information for clinical care.
Participants are women aged 25 to 75 with a recent breast cancer diagnosis who will receive neoadjuvant chemotherapy or surgery. During the study, various imaging markers related to breast cancer subtypes and clinical outcomes are measured and compared. The primary outcome is the association between FCH PETMR parameters and breast cancer molecular subtypes, with follow-up lasting at least 40 weeks. Secondary outcomes include links to histologic grade and prognosis. Radiation exposure is monitored and is comparable to routine chest CT scans, with safety considerations in place throughout the study period.
CONDITIONS
Brief Title
Fluorocholine PET/MR in Breast Cancer
Research Team
J
Jane Wang, M.D.
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Women diagnosed with breast cancer by pathological diagnosis from a core biopsy within 3 months and who will receive neoadjuvant chemotherapy before surgery; or women with pathologically proven breast cancer within 3 months who will receive operation without pre-operative neoadjuvant chemotherapy
Women whose Eastern Cooperative Oncology Group (ECOG) performance status is between 0-2
Women with life expectancy of at least 3 months
You will not qualify if you...
Women who are unable to cooperate with the examinations
Women who are pregnant, lactating, or planning to be pregnant
Women with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2 or acute renal failure within 3 months, or with past history of renal dialysis
Past history of claustrophobia
Past history of anaphylactoid reactions to MRI contrast agents or PET tracer agents
Women with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, or recent coronary artery stent placement within 3 months
Past history of breast cancer or other malignancy within 5 years
Women who underwent chemotherapy within a year
Women deemed unsuitable for the study by investigators
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Imaging Procedures
Duration - Up to 2 weeks
Participants will undergo two separate imaging sessions: a whole-body PET/MR scan using FDG and a breast PET/MR scan using Fluorocholine with MRI contrast. Fasting is required before each scan, which are scheduled at least 2 days apart.
2 visits on separate days
Follow-up
Duration - At least 40 weeks
Researchers will analyze imaging results and monitor clinical outcomes, including treatment response and survival, for at least 40 weeks after enrollment.
Periodic follow-up assessments
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Reliability of 18F-FDG PET Metabolic Parameters Derived Using Simultaneous PET/MRI and Correlation With Prognostic Factors of Invasive Ductal Carcinoma: A Feasibility Study.
MR Imaging Radiomics Signatures for Predicting the Risk of Breast Cancer Recurrence as Given by Research Versions of MammaPrint, Oncotype DX, and PAM50 Gene Assays.
Positron Emission Tomography/Magnetic Resonance Imaging for Local Tumor Staging in Patients With Primary Breast Cancer: A Comparison With Positron Emission Tomography/Computed Tomography and Magnetic Resonance Imaging.
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