Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET-MRI (PET/MR) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single arm
- description
- Women diagnosed with 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 who will undergo surgery (without preoperative neoadjuvant chemotherapy).
- interventionNames
- Diagnostic Test: PET-MRI (PET/MR)
Primary outcomes (1)
- measure
- Association Between Pre-treatment FCH PET/MR Parameters and Molecular Subtypes of Breast Cancer
- timeFrame
- From enrollment to the end of study (follow up) at least 40 weeks.
- description
- To evaluate the association between pre-treatment FCH PET/MR imaging parameters and molecular subtypes of breast cancer, as well as their predictive diagnostic performance.
Secondary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. 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 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.
References
Publications (10)
- BACKGROUNDPujara 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
- BACKGROUNDGrueneisen 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.0000000000000197. PMID 26115367
- BACKGROUNDGoorts B, Voo S, van Nijnatten TJA, Kooreman LFS, de Boer M, Keymeulen KBMI, Aarnoutse R, Wildberger JE, Mottaghy FM, Lobbes MBI, Smidt ML. Hybrid 18F-FDG PET/MRI might improve locoregional staging of breast cancer patients prior to neoadjuvant chemotherapy. Eur J Nucl Med Mol Imaging. 2017 Oct;44(11):1796-1805. doi: 10.1007/s00259-017-3745-x. Epub 2017 Jun 10. PMID 28600647
- BACKGROUNDBotsikas D, Bagetakos I, Picarra M, Da Cunha Afonso Barisits AC, Boudabbous S, Montet X, Lam GT, Mainta I, Kalovidouri A, Becker M. What is the diagnostic performance of 18-FDG-PET/MR compared to PET/CT for the N- and M- staging of breast cancer? Eur Radiol. 2019 Apr;29(4):1787-1798. doi: 10.1007/s00330-018-5720-8. Epub 2018 Sep 28. PMID 30267154
- BACKGROUNDJena A, Taneja S, Singh A, Negi P, Sarin R, Das PK, Singhal M. Reliability of 18F-FDG PET Metabolic Parameters Derived Using Simultaneous PET/MRI and Correlation With Prognostic Factors of Invasive Ductal Carcinoma: A Feasibility Study. AJR Am J Roentgenol. 2017 Sep;209(3):662-670. doi: 10.2214/AJR.16.17766. Epub 2017 Jul 5. PMID 28678576
- BACKGROUNDCho 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.