Actively Recruiting
Fluorocholine PET/MR in Breast Cancer
Led by Taipei Veterans General Hospital, Taiwan · Updated on 2026-05-14
195
Participants Needed
1
Research Sites
319 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Objectives: Our study is conducted to use the pre-treatment FCH PET/MR in breast cancer patients, to investigate whether the conventional PET/MR imaging markers (SUVmax, MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, ADC analysis), and FCH/MR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for prediction purposes. Primary study purposes: -To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for prediction purpose. Secondary study purposes: \- To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with the factors related to clinical outcomes (histologic grade, prognosis) and to analyze which parameters are more accurate for prediction purposes. Test drug: Name: 18F- Fluorocholine (18F-FCH) Dosage form: N-(\[18F\]fluoromethyl)-2-hydroxy-N,N-dimethylethan-1-aminium Strength: 3-5 MBq/kg per patient (5-6 mCi/mL at time of injection (TOI)) Dosage and administration: Intravenous injection. Selection criteria: 1. Women aged 25-75 years old. 2. Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy). 3. Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.
CONDITIONS
Official Title
Fluorocholine PET/MR in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 25-75 years old
- Diagnosed with breast cancer by pathological diagnosis from core biopsy within 3 months
- Planning to receive neoadjuvant chemotherapy before surgery or operation without pre-operative neoadjuvant chemotherapy
- ECOG performance status between 0-2
- Life expectancy of at least 3 months
You will not qualify if you...
- Unable to cooperate with the examinations
- Pregnant, lactating, or planning to become pregnant
- Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2 or acute renal failure within 3 months
- Past history of renal dialysis
- History of claustrophobia
- History of anaphylactoid reactions to MRI contrast agents or PET tracer agents
- Presence of 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
- Received chemotherapy within the past year
- Assessed by investigators as not suitable to join the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Taipei Veterans General Hospital
Taipei, Taiwan, Taiwan, 11217
Actively Recruiting
Research Team
J
Jane Wang, M.D.
CONTACT
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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