Overview
- 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:
- Women aged 25-75 years old.
- 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).
- Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.
Description
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/mL (at time of injection, TOI) 18F-Fluorodeoxyglucose (FDG), the participant will take a bed rest of about 60 minutes, then a 20-25 minutes of whole body PET/MR will be performed. FDG is a commercialized PET tracer and approved for clinical diagnosis.
3\. PET/MR of the breast:
- . The participant will undergo 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, then undergoes 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 media, 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).
4\. The whole body FDG PET/MR, and the breast FCH PET/MR will be performed on different days (interval \>= 2 days).
5\. 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.
6\. The radiation dose (effective dose equivalent, EDE) of a whole body FDG PET/MR measures about 6.6 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 a very low estimated secondary cancer occurrence (about 5/10000 to 7/10000). Most of the radiation by FDG and FCH will be decayed, and minimal portion of them will be excreted by urine and hepatobiliary system.
Eligibility
Inclusion Criteria:
- Women aged 25-75 years old.
- 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).
- Women whose ECOG between 0-2 points and life expectancy ≧ 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 GFR (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 (\<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.
