Fluorocholine PET/MR in Breast Cancer
Recruiting · NCT07587086 · Observational (researchers observe without assigning treatment) · Lead sponsor: Taipei Veterans General Hospital, Taiwan
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Taipei Veterans General Hospital - Taipei, Taiwan, Taiwan