Fluorocholine PET/MR in Breast Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age25-75
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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:

1. Women aged 25-75 years old. 2. 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). 3. Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PET-MRI

Treatment groups

195 Participants
are divided into 1 treatment group