Fluorocholine PET/MR in Breast Cancer

Официальное название

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

Обзор

Objectives: Our study is conducted to use the pre-treatment Fluorocholine (FCH) Positron emission tomography/magnetic resonance (PET/MR) imaging in breast cancer patients, to investigate whether the conventional PET/MR imaging markers (maximum standardized uptake value \[SUVmax\], MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, apparent diffusion coefficient \[ADC\] analysis), and FCH PET/MR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for predictive 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 predictive purposes. 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 predictive 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.fluoromethyl Selection criteria: 1. Women aged 25-75 years old. 2. 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). 3. Women whose Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 and life expectancy at least 3 months.

Подробное описание

Study steps / procedures:

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

3\. PET/MR of the breast:

1. . The participant will undergo fasting (nothing by mouth, nil per os \[NPO\]) for at least 6 hours before the examination. 2. . 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).

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

Вмешательства

• Диагностический тест PET-MRI (PET/MR)
  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 at least 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.

Первичные конечные точки

• Association Between Pre-treatment FCH PET/MR Parameters and Molecular Subtypes of Breast Cancer [Срок оценки: From enrollment to the end of study (follow up) at least 40 weeks.]

Вторичные конечные точки (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 predictive purposes. [Срок оценки: From enrollment, at least about 40 weeks (until the completion of chemotherapy, or when the surgical pathology comes out).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Тайвань · 1 центр

• Taipei Veterans General Hospital — Taipei

Публикации

• Pujara AC, Kim E, Axelrod D, Melsaether AN. PET/MRI in Breast Cancer. J Magn Reson Imaging. 2019 Feb;49(2):328-342. doi: 10.1002/jmri.26298. Epub 2018 Oct 6. PMID 30291656
• Grueneisen J, Nagarajah J, Buchbender C, Hoffmann O, Schaarschmidt BM, Poeppel T, Forsting M, Quick HH, Umutlu L, Kinner S. Positron Emission Tomography/Magnetic Resonance Imaging for Local Tumor Staging in Patients With Primary Breast Cancer: A Comparison With Positron Emission Tomography/Computed Tomography and Magnetic Resonance Imaging. Invest Radiol. 2015 Aug;50(8):505-13. doi: 10.1097/RLI.00 PMID 26115367
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• Cho N, Im SA, Cheon GJ, Park IA, Lee KH, Kim TY, Kim YS, Kwon BR, Lee JM, Suh HY, Suh KJ. Integrated 18F-FDG PET/MRI in breast cancer: early prediction of response to neoadjuvant chemotherapy. Eur J Nucl Med Mol Imaging. 2018 Mar;45(3):328-339. doi: 10.1007/s00259-017-3849-3. Epub 2017 Nov 4. PMID 29101445
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• Li H, Zhu Y, Burnside ES, Huang E, Drukker K, Hoadley KA, Fan C, Conzen SD, Zuley M, Net JM, Sutton E, Whitman GJ, Morris E, Perou CM, Ji Y, Giger ML. Quantitative MRI radiomics in the prediction of molecular classifications of breast cancer subtypes in the TCGA/TCIA data set. NPJ Breast Cancer. 2016;2:16012-. doi: 10.1038/npjbcancer.2016.12. Epub 2016 May 11. PMID 27853751

Идентификаторы

NCT: NCT07587086 · 2020-03-005A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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