18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
FLT PET, breast neoplasms, mammography, breast ultrasound
Study Type
Study Phase
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Name: 18F-FLT
Type: Drug
Overall Status
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.
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.
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
National Taiwan University Hospital
National Taiwan University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page