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

Not Applicable

• Conditions: Breast Neoplasms
• Interventions: Drug: 18F-FLT

• Registration Number: NCT01713049
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2010-08
• Study Start: 2010-08
• Study First Submitted: 2012-10-21
• Study First Submitted QC: 2012-10-23
• Last Update Submitted: 2012-10-23
• Study First Posted: 2012-10-24
• Last Update Posted: 2012-10-24
• Primary Completion: 2012-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medical Imaging NTUH; 🇨🇳 Taipei, Taiwan