Clinical Trials Logo
  1. Home
  2. Magnetic Resonance Imaging
  3. NCT01956409

Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis

Magnetic Resonance Imaging Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

In recent years, the application of 18F-FDG PET (positron emission tomography) and MRI for breast lesion diagnosis was emerging. Imbriaco et al compared the diagnostic performance of 18F-FDG PET and MRI for suspicious breast lesions, with PET showing a sensitivity of 80% and specificity 100%; and MRI revealed a sensitivity of 95% and specificity of 98%. Lim et al studied 18F-FDG PET-CT with MRI to monitor treatment response for breast cancer patients receiving NAC, with a sensitivity 70% and specificity 72%, and can detect the treatment response earlier than conventional imaging.

However, 18F-FDG is not tumor specific, and searching for an alternative tracer agent as a tumor biomarker is necessary. 18F-Fluorocholine (FCH), a choline analog, was used for diagnosis of prostate cancer, hepatocellular carcinoma (HCC), bronchioloalveolar carcinoma, brain tumor, since malignant tumors show higher choline metabolites than benign lesions; it was reported that FCH PET showed higher sensitivity (88-94%) than 18F-FDG PET (59-68%) in detecting HCC. FCH PET was used for staging for prostate cancer, with FCH PET-CT can provide sufficient information for management with an accuracy of 88%. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01956409
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Active, not recruiting
Phase Phase 4
Start date September 2012
Completion date March 2017
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03785171 - Predicative Value of Multimodal MRI in Moyamoya Disease
Not yet recruiting NCT03726788 - Intra Articular Injection of Botulinum Toxin Versus Corticoids in Gonarthrosis Phase 2
Completed NCT01660841 - Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging Phase 3
Recruiting NCT03635619 - The Application of 3T MRI in Esophageal Cancer
Recruiting NCT03658343 - T2* MRI Analysis for Sarcoma N/A
Recruiting NCT04555642 - Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
Active, not recruiting NCT03441867 - Neuroimaging Biomarker for Seizures N/A
Recruiting NCT04850001 - Cognitive Decline in Asymptomatic Intracranial Stenosis Patients: A 1-Year Follow-Up Study
Not yet recruiting NCT05816213 - Point-of-care Low-field MRI in Acute Stroke
Active, not recruiting NCT05498623 - MR Fingerprinting for Diagnostic of Prostate Cancer
Recruiting NCT04996615 - Artificial Intelligence Analysis for Magnetic Resonance Imaging in Screening Breast Cancer in High-risk Women
Recruiting NCT04257747 - Qualitative and Quantitative Evaluation of Vascular Flows of Radial, Ulnar and Interdigital Arterial Trees Under Normal and Pathological Conditions by 3 Tesla MRI N/A
Recruiting NCT05889117 - Brain Stimulation for Concussion N/A
Completed NCT02540967 - Drug Use Investigation of Gadovist.
Completed NCT05103189 - 4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension N/A
Completed NCT02567318 - Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? N/A
Recruiting NCT02834585 - Magnetic Resonance Imaging or Ultrasound in Soft Tissue Tumors (MUSTT) N/A
Active, not recruiting NCT02446665 - Disease Status in Primary Sclerosing Cholangitis by Elastography N/A
Completed NCT01721785 - Diagnostic Value of Novel MR Imaging Techniques for the Primary Staging and Restaging of Rectal Cancer N/A
Completed NCT01223404 - Nicotinic Modulation of the Default Network N/A