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18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
FLT PET, breast neoplasms, mammography, breast ultrasound
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Intervention
Name: 18F-FLT
Type: Drug
Overall Status
Recruiting
Summary
The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound.
Detailed Description
1. To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard, and to determine whether 18F-FLT PET can increase the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy.
2. To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer diagnosis.
2. To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer diagnosis.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 20 Years
Gender: Female
Criteria: Inclusion Criteria:
1. Women aged between 20 to 80 years
2. women who have localized findings on mammography and / or ultrasound and will receive biopsy.
3. The lesions on the conventional imaging measure >=1cm
4. WBC count >=3000/L, or platelet>=75,000/L
5. Liver function, AST or ALT < 78 U/L
6. Renal function, Creatinine < 2.0 mg/dl.The laboratory examinations should be performed within 4months before our study.
Exclusion Criteria:
1. Pregnant women or who are planning to be pregnant.
2. Known cancers in other organs.
3. Women who are not able to cooperate with the PET/CT examination.
1. Women aged between 20 to 80 years
2. women who have localized findings on mammography and / or ultrasound and will receive biopsy.
3. The lesions on the conventional imaging measure >=1cm
4. WBC count >=3000/L, or platelet>=75,000/L
5. Liver function, AST or ALT < 78 U/L
6. Renal function, Creatinine < 2.0 mg/dl.The laboratory examinations should be performed within 4months before our study.
Exclusion Criteria:
1. Pregnant women or who are planning to be pregnant.
2. Known cancers in other organs.
3. Women who are not able to cooperate with the PET/CT examination.
Location
Department of Medical Imaging NTUH
Taipei, Taiwan
Status: Recruiting
Contact: Jane Wang, MD, PhD - +886-2-23123456 - hstjen@yahoo.com.tw
Start Date
August 2010
Completion Date
December 2013
Sponsors
National Taiwan University Hospital
Source
National Taiwan University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page