Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Multihance

Magnevist

Gianpaolo Pirovano, MD

To show if one MRI contrast agent is better than another one in the diagnosis of malignant breast lesions compared to histopathology

Multihance Versus Magnevist in Breast MRI

Phase III Multicenter Double-Blind, Randomized, Crossover Study to Compare MultiHance With Magnevist in Contrast-enhanced Magnetic Resonance Imaging (MRI) of the Breast

Bracco Diagnostics, Inc

Gianpaolo Pirovano, M.D., Executive Director, Corporate Medical Development

Nervous System Diseases

Symptoms and General Pathology

Brain Neoplasms

Neoplasm Metastasis

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Magnevist (SH L 451A)

Magnevist at a dose of 0.1 mmol/kg and another 0.1 mmol/kg 30minutes later.

Bayer Study Director

To verify the number of metastatic brain tumors detected in contrast-enhanced MRI, which is the primary variable, increases after an additional dose of Magnevist (SH L 451A) comparing images after an initial dose (0.1 mmol/kg) with those after an additional dose (0.1 mmol/kg, a total dose of 0.2 mmol/kg) intra-individually in patients with metastatic brain tumors. Safety was also to be assessed.

Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis

Intra-individual Comparison Study of Intravenously Administered Magnevist (SH L 451A) on Lesion Detection Ability in MRI After an Initial Dose of 0.1 mmol/kg and After an Additional Dose of 0.1 mmol/kg in Patients With Metastatic Brain Tumor

Bayer

Breast Diseases

Skin Diseases

To investigate the diagnostic accuracy of 18F-Fluorocholine PET and proton MR spectroscopy of breast lesions, using pathology as gold standard.

18F-FCH

Jane Wang, PhD

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.

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%.

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

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.

For the breast cancer patients who will undergo chemotherapy treatment, we aim to use 18F-FCH PET before and after chemotherapy. And the changes of tracer uptake of 18F-FCH on PET scans before and after chemotherapy will be correlated with clinical outcomes before and after chemotherapy, to investigate whether 18F-FCH PET results can monitor treatment response of chemotherapy.

The investigators use the interpretation results of breast MRI (with MR spectroscopy in the examination) for breast lesion diagnosis, with the pathology result of the breast lesions as gold standards, and to investigate how well the breast MRI study can correctly diagnose the true nature of breast lesions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multihance Versus Magnevist in Breast MRI	NCT00486473	Breast Cancer	Multihance Magnevist	18 Years -	Bracco Diagnostics, Inc
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Patients With Brain Metastasis	NCT00681551	Brain Neoplasms	Magnevist (SH L... Magnevist (SH L...	20 Years -	Bayer
Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis	NCT01956409	Breast Cancer D... Positron Emissi... Magnetic Resona...	18F-FCH Magnevist	20 Years - 75 Years	National Taiwan University Hospital

Spots Global Cancer Trial Database for magnevist

Every month we try and update this database with for magnevist cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for magnevist

Every month we try and update this database with for magnevist cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for magnevist cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.