Fluorocholine PET/MR in Breast Cancer

Recruiting now

Conditions studied: Breast Neoplasms, Female

In brief

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 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 predictive 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.ﬂuoromethyl Selection criteria: 1. Women aged 25-75 years old. 2. 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). 3. Women whose Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and life expectancy at least 3 months.

Key facts

Study ID: NCT07587086
Run by: Taipei Veterans General Hospital, Taiwan
People needed: 195
Starts: 2022-06-14
Expected to finish: 2028-07-31
Last updated by the study team: 2026-07-06

Who can join

Age: 25 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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 is running

Taipei Veterans General Hospital — Taipei, Taiwan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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