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Trial Title:
18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound
NCT ID:
NCT01713049
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Alovudine
Conditions: Keywords:
FLT PET
breast neoplasms
mammography
breast ultrasound
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
18F-FLT
Description:
0.07 mCi/kg of 18F-FDG will be injected intravenously. The data acquisition will be
started at 90 minutes after the injection using 2-D acquisition from a GE DISCOVERY ST
PET/CT scanner (GE Medical Systems, Milwaukee, WI).
Arm group label:
18F-FLT
Other name:
FLT
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.
Criteria for eligibility:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Medical Imaging NTUH
Address:
City:
Taipei
Zip:
100
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Jane Wang, MD, PhD
Phone:
+886-2-23123456
Phone ext:
65565
Email:
hstjen@yahoo.com.tw
Start date:
August 2010
Completion date:
December 2013
Lead sponsor:
Agency:
National Taiwan University Hospital
Agency class:
Other
Source:
National Taiwan University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01713049
