Fluorocholine PET/MR in Breast Cancer

Study steps / procedures:

• The study participants will receive pre-treatment whole-body PET/MR and breast PET/MR examinations.
• The whole-body PET/MR:

(1). The participant will undergo NPO for at least 6 hours before the examination.

(2). After intravenous injection of 5-6 mCi 18F- Fluorodeoxyglucose (FDG), the participant will rest for approximately 60 minutes, followed by a 20-25-minute whole-body PET/MR examination. FDG is a commercially available PET tracer approved for clinical diagnosis.

• PET/MR of the breast:

• . The participant will undergo fasting (nothing by mouth, nil per os [NPO]) for at least 6 hours before the examination.
• . After intravenous injection of 5-6 mCi/mL (at TOI) 18F-Fluorocholine (FCH), the study participant will take a 45-60-minute bed rest and then undergo a breast PET/MR with prone position. The breast PET/MR will take about 30-35 minutes. The intravenous injection of MRI contrast media will be performed during the examination (MRI-contrast agent, Dotarem [Gadoteric acid, Guerbet, France] is commercialized and routinely used in MRI examination). The dosage of MRI contrast media ranges from 10-15 cc according to various body weight (0.1mmol/Kg).

• The whole-body FDG PET/MR, and the breast FCH PET/MR will be performed on different days (interval of at least 2 days).

• The study results will be interpreted by board certified diagnostic radiologists and nuclear medicine physicians, and relayed to the patient's physicians for reference of clinical management.

• The radiation dose (effective dose equivalent, EDE) of a whole-body FDG PET/MR measures about 6.6 millisievert [mSv], the EDE of a FCH breast PET/MR measures about 3.85 mSv, totally about 10.45 mSv, which is relatively equivalent to that of a chest CT scan (without and with contrast, 10.8 mSv), resulting in a very low estimated risk of secondary cancer (about 5/10000 to 7/10000). Most of the radioactivity from FDG and FCH will decay naturally, and only a minimal portion will be excreted through the urinary and hepatobiliary systems.

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.