Actively Recruiting

Age: 25Years - 75Years
FEMALE
NCT07587086

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

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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

Age: 25Years - 75Years
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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