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

National Taiwan University Hospital70 enrolled

Overview

The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Breast Neoplasms

Interventions

18F-FLTDRUG

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).

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Medical Imaging NTUH

Taipei, Taiwan

RECRUITING

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.