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

Primary Purpose

Breast Cancer Diagnosis, Positron Emission Tomography, Magnetic Resonance Imaging

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
18F-FCH
Magnevist
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer Diagnosis focused on measuring breast neoplasms, 18F-FCH PET, MRI

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

diagnostic accuracy of PET and MR spectroscopy

Arm Description

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

Outcomes

Primary Outcome Measures

diagnostic accuracy of 18F-FCH PET for breast cancer diagnosis
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 Outcome Measures

Monitoring of treatment response of breast cancer to chemotherapy using 18F-FCH PET
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.
diagnostic accuracy of breast MR spectroscopy for breast cancer diagnosis
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.

Full Information

First Posted
September 25, 2013
Last Updated
February 3, 2016
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01956409
Brief Title
Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: To investigate and compare the diagnostic performance of proton MRS and FCH PET for localized findings on mammography and breast ultrasound. To investigate whether FCH PET findings are correlated with choline signals on proton MRS. 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. 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. To investigate the usefulness of FCH PET for whole body staging for breast cancer patients.
Detailed 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Diagnosis, Positron Emission Tomography, Magnetic Resonance Imaging
Keywords
breast neoplasms, 18F-FCH PET, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
diagnostic accuracy of PET and MR spectroscopy
Arm Type
Experimental
Arm Description
To investigate the diagnostic accuracy of 18F-Fluorocholine PET and proton MR spectroscopy of breast lesions, using pathology as gold standard.
Intervention Type
Drug
Intervention Name(s)
18F-FCH
Other Intervention Name(s)
N,N-Dimethyl-N-Fluoromethylethanolamine
Intervention Type
Drug
Intervention Name(s)
Magnevist
Other Intervention Name(s)
Gadopentetate dimeglumine
Primary Outcome Measure Information:
Title
diagnostic accuracy of 18F-FCH PET for breast cancer diagnosis
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Monitoring of treatment response of breast cancer to chemotherapy using 18F-FCH PET
Description
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.
Time Frame
5 years
Title
diagnostic accuracy of breast MR spectroscopy for breast cancer diagnosis
Description
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.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Evaluation the correlation of 18F-FCH PET and breast MRI
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Wang, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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