Fluorocholine PET/MR imaging in breast cancer patients before treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses pre-treatment Fluorocholine PET/MR imaging in women with breast cancer to explore associations between imaging markers (SUVmax, MR choline, dynamic contrast-enhanced MRI, ADC), radiomic features, and deep learning analyses with molecular subtypes, treatment response, and survival. Participants undergo separate pre-treatment whole-body FDG PET/MR and breast FCH PET/MR scans on different days, interpreted by radiologists and nuclear medicine physicians. The goal is to identify imaging parameters that may accurately predict disease characteristics and clinical outcomes. Results may inform personalized treatment planning for breast cancer patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Taipei Veterans General Hospital
  Taipei, Taiwan, Taiwan Recruiting

Study contacts

• Study coordinator: Jane Wang, M.D.
• Email: jwang2@vghtpe.gov.tw
• Phone: +886938591583

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.