Clinical trial · Interventional
Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis
Use of Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis, Prediction of Clinical Outcome and Monitoring of Treatment Response to Neoadjuvant Chemotherapy
- 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)
The application of FCH PET in breast cancer diagnosis has not been reported. We hypothesize that FCH reveals choline metabolic profiles of breast cancers, and shows the similar pathophysiological mechanism to choline on proton MRS, and our study goals are: 1. To investigate and compare the diagnostic performance of proton MRS and FCH PET for localized findings on mammography and breast ultrasound. 2. To investigate whether FCH PET findings are correlated with choline signals on proton MRS. 3. To evaluate if choline, water and lipid signals on proton MRS, FCH PET are associated with factors related to clinical outcome and prognosis- that is, molecular markers, tumor staging, histologic grade of breast cancers. 4. For localized advanced breast cancer, to investigate the treatment response to NAC using proton MRS and FCH PET, and to evaluate which modality is more sensitive. 5. To investigate the usefulness of FCH PET for whole body staging for breast cancer patients.
Conditions
Conditions (3)
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 Cancer Diagnosis | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Magnetic Resonance Imaging | — | UNRESOLVED | — |
| Positron Emission Tomography | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FCH | Drug | — | UNRESOLVED |
| Magnevist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- diagnostic accuracy of PET and MR spectroscopy
- description
- To investigate the diagnostic accuracy of 18F-Fluorocholine PET and proton MR spectroscopy of breast lesions, using pathology as gold standard.
- interventionNames
- Drug: 18F-FCH
- Drug: Magnevist
Primary outcomes (1)
- measure
- diagnostic accuracy of 18F-FCH PET for breast cancer diagnosis
- timeFrame
- 5 years
- description
- The investigators use the interpretation results of 18F-FCH PET for breast lesion diagnosis, with the pathology result of the breast lesions as gold standards, and to investigate how well the 18F-FCH PET can correctly diagnose the true nature of breast lesions.
Secondary outcomes (2)
- measure
- Monitoring of treatment response of breast cancer to chemotherapy using 18F-FCH PET
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 20-75 years old. * with localized findings on mammography or breast ultrasound in recent 3 months and who will receive breast biopsy or excision for the findings; or with recently diagnosed LABC who will receive NAC. Exclusion Criteria: * unable to cooperate with the examinations * pregnant or planning to be pregnant * estimated GFR (eGFR) \< 60 ml/min/1.73m2 or with recent acute renal failure, past history of renal dialysis. * Past history of claustrophobia * Past history of anaphylactoid reactions to MRI contrast agents or PET tracer agents. * with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (\<2 months). * Past history of breast cancer or other malignancy (treated within 5 years). * lactating.
References
Publications (0)
Data not yet available