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Clinical Trials/NCT01713049
NCT01713049
Unknown
Not Applicable

Use of 18F-FLT Positron Emission Tomography to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: A Pilot Study

National Taiwan University Hospital1 site in 1 country70 target enrollmentAugust 2010
Interventions18F-FLT
Drugs18F-FLT

Overview

Phase
Not Applicable
Intervention
18F-FLT
Conditions
Breast Neoplasms
Sponsor
National Taiwan University Hospital
Enrollment
70
Locations
1
Primary Endpoint
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.
Last Updated
13 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
December 2013
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

National Taiwan University Hospital

National Taiwan University Hospital

National Taiwan University Hospital

Eligibility Criteria

Inclusion Criteria

  • Women aged between 20 to 80 years
  • women who have localized findings on mammography and / or ultrasound and will receive biopsy.
  • The lesions on the conventional imaging measure \>=1cm
  • WBC count \>=3000/L, or platelet\>=75,000/L
  • Liver function, AST or ALT \< 78 U/L
  • Renal function, Creatinine \< 2.0 mg/dl.The laboratory examinations should be performed within 4months before our study.

Exclusion Criteria

  • Pregnant women or who are planning to be pregnant.
  • Known cancers in other organs.
  • Women who are not able to cooperate with the PET/CT examination.

Arms & Interventions

18F-FLT

18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound.

Intervention: 18F-FLT

Outcomes

Primary Outcomes

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.

Time Frame: The biopsy procedures will be scheduled as soon as possible and should be finished within 2 months after 18F-FLT PET.

Study Sites (1)

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