RecruitingNCT07587086

Fluorocholine PET/MR in Breast Cancer

Use of Imaging Markers by Fluorocholine PET/MR to Predict Molecular Subtypes and Clinical Outcomes of Breast Cancer: a Pilot Study


Sponsor

Taipei Veterans General Hospital, Taiwan

Enrollment

195 participants

Start Date

Jun 14, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 25 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria9

  • 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.

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Interventions

DIAGNOSTIC_TESTPET-MRI

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.


Locations(1)

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

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NCT07587086


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