Actively Recruiting

Age: 25Years - 75Years
FEMALE
ID07587086

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

Led by Taipei Veterans General Hospital, Taiwan · Updated on 2026-05-14

195

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying breast cancer in women aged 25 to 75 using advanced imaging techniques to better understand how certain imaging markers relate to breast cancer types, treatment responses, and patient outcomes. The study aims to determine which imaging features are most accurate for predicting these clinical aspects. This observational research focuses on pre-treatment imaging and its association with cancer characteristics and prognosis. Participants will undergo two types of imaging scans before treatment: a whole body PET/MR scan with a tracer called FDG and a breast-specific PET/MR scan using a tracer called 18F-Fluorocholine (FCH). These scans are performed on separate days with at least a two-day interval. The breast scan includes the use of MRI contrast dye during the procedure. Medical imaging experts will analyze the results and share findings with the patients' doctors to aid clinical decisions. During the study, participants will fast for at least six hours before imaging. The research team will monitor imaging markers linked to breast cancer subtypes and clinical factors like tissue grade and prognosis. The main outcome is the relationship between FCH PET/MR imaging and cancer types, assessed over at least 40 weeks from enrollment. Secondary outcomes include links to prognosis and treatment responses. Radiation exposure from the imaging is low and comparable to a chest CT scan. Participants' safety and ongoing medical care will be supported throughout the study.

CONDITIONS

Brief Title

Fluorocholine PET/MR in Breast Cancer

Who Can Participate

Age: 25Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 25-75 years old
  • Diagnosed with breast cancer by pathological diagnosis from core biopsy within 3 months
  • Planning to receive neoadjuvant chemotherapy before surgery or surgery without pre-operative chemotherapy
  • ECOG performance status between 0 and 2
  • Life expectancy of at least 3 months
Not Eligible

You will not qualify if you...

  • Unable to cooperate with examinations
  • Pregnant, lactating, or planning pregnancy
  • Estimated GFR less than 60 ml/min/1.73m2 or acute renal failure within 3 months, history of dialysis
  • History of claustrophobia
  • Past anaphylactoid reactions to MRI contrast or PET tracer agents
  • Presence of cardiac pacemaker, aneurysmal clip, mechanical valve replacement, or coronary stent placed within 3 months
  • History of breast cancer or other cancers within 5 years
  • Chemotherapy received within the last year
  • Deemed unsuitable to join by investigators

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 1 week

Participants will undergo pre-treatment whole body FDG PET/MR and breast FCH PET/MR examinations performed on different days with at least 2 days interval.

2 visits (in-person) on separate days

Long-term Monitoring

Duration - At least 40 weeks

Participants will be followed for at least 40 weeks to evaluate clinical outcomes and imaging marker associations with breast cancer molecular subtypes and prognosis.

Visit schedule depends on clinical management and follow-up, not dictated by the study

Trial Site Locations

Total: 1 location

1

Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan, 11217

Actively Recruiting

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Research Team

J

Jane Wang, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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.

Johannes Grueneisen, James Nagarajah, Christian Buchbender...

https://pubmed.ncbi.nlm.nih.gov/26115367

Hybrid 18F-FDG PET/MRI might improve locoregional staging of breast cancer patients prior to neoadjuvant chemotherapy.

Briete Goorts, Stefan Vöö, Thiemo J A van Nijnatten...

https://pubmed.ncbi.nlm.nih.gov/28600647

What is the diagnostic performance of 18-FDG-PET/MR compared to PET/CT for the N- and M- staging of breast cancer?

Diomidis Botsikas, Ilias Bagetakos, Marlise Picarra...

https://pubmed.ncbi.nlm.nih.gov/30267154

Reliability of 18F-FDG PET Metabolic Parameters Derived Using Simultaneous PET/MRI and Correlation With Prognostic Factors of Invasive Ductal Carcinoma: A Feasibility Study.

Amarnath Jena, Sangeeta Taneja, Aru Singh...

https://pubmed.ncbi.nlm.nih.gov/28678576

Multiparametric Evaluation of Treatment Response to Neoadjuvant Chemotherapy in Breast Cancer Using Integrated PET/MR.

Jane Wang, Tiffany Ting-Fang Shih, Ruoh-Fang Yen

https://pubmed.ncbi.nlm.nih.gov/28481792

Quantitative MRI radiomics in the prediction of molecular classifications of breast cancer subtypes in the TCGA/TCIA data set.

Hui Li, Yitan Zhu, Elizabeth S Burnside...

https://pubmed.ncbi.nlm.nih.gov/27853751

MR Imaging Radiomics Signatures for Predicting the Risk of Breast Cancer Recurrence as Given by Research Versions of MammaPrint, Oncotype DX, and PAM50 Gene Assays.

Hui Li, Yitan Zhu, Elizabeth S Burnside...

https://pubmed.ncbi.nlm.nih.gov/27144536