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

This trial does not accept healthy volunteers

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 population

The 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • PET-MRI

    Diagnostic test

    1. The study participants will receive pre-treatment whole body PET/MR and breast PET/MR examinations. 2. The whole body PET/MR 3. PET/MR of the breast 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.

Treatment groups

195 Participants
are divided into 1 treatment group
Group A: Single arm1 intervention

Trial outcomes

Primary outcomes

1

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.

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

Time frame
From enrollment to the end of study (follow up) at least 40 weeks

Secondary outcomes

1

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.

The results to be predicted, including: clinical outcomes (histologic grade, recurrence rate (at 1, 2, 5 years after surgery), survival (5-year overall survival and disease/recurrence-free survival).

Time frame
From enrollment, at least about 40 weeks (until the completion of chemotherapy, or when the surgical pathology comes out).

Other outcomes

Sponsors and contacts

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