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Fluorocholine PET/MR in Breast Cancer

Recruitingn/aAges 25 Years - 75 YearsFemaleTaipei Veterans General Hospital, Taiwan
NCT07587086 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Objectives: Our study is conducted to use the pre-treatment Fluorocholine (FCH) Positron emission tomography/magnetic resonance (PET/MR) imaging in breast cancer patients, to investigate whether the conventional PET/MR imaging markers (maximum standardized uptake value \[SUVmax\], MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, apparent diffusion coefficient \[ADC\] analysis), and FCH PET/MR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for predictive 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 predictive purposes. Secondary study purposes: -To investigate whether the

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women aged 25-75 years old. * Women diagnosed with breast cancer by pathological diagnosis from a 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). * Women whose ECOG performance status between 0-2 and life expectancy at least 3 months. Exclusion Criteria: * Women who are unable to cooperate with the examinations * Women who are pregnant, lactating or are planning to be pregnant * Women with estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2 or acute renal failure within 3 months, 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, recently applied coronary artery stent (within 3 months). * Past history of breast cancer or other malignancy within 5 years. * Women who underwent chemotherapy within a year. * Women who are not suitable to join the study according to the assessment by investigators.
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What it tests

  • PET-MRI (PET/MR)
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Where

1 site
Taipei Veterans General Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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