Fluorocholine PET/MR in Breast Cancer

May 8, 2026 updated by: Taipei Veterans General Hospital, Taiwan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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/mL (at time of injection, TOI) 18F-Fluorodeoxyglucose (FDG), the participant will take a bed rest of about 60 minutes, then a 20-25 minutes of whole body PET/MR will be performed. FDG is a commercialized PET tracer and approved for clinical diagnosis.

3. PET/MR of the breast:

  1. . The participant will undergo 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, then undergoes 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 media, 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 >= 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 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 a very low estimated secondary cancer occurrence (about 5/10000 to 7/10000). Most of the radiation by FDG and FCH will be decayed, and minimal portion of them will be excreted by urine and hepatobiliary system.

Study Type

Observational

Enrollment (Estimated)

195

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Jane Wang, M.D.
        • Sub-Investigator:
          • Ling-Ming Tseng, M.D
        • Sub-Investigator:
          • Ko-Han Lin, M.D.
        • Sub-Investigator:
          • Yi-Fang Tsai, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single arm
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).
Diagnostic test: PET-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
From enrollment to the end of study (follow up) at least 40 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: From enrollment, at least about 40 weeks (until the completion of chemotherapy, or when the surgical pathology comes out).
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).
From enrollment, at least about 40 weeks (until the completion of chemotherapy, or when the surgical pathology comes out).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-03-005A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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