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

National Taiwan University

Status: Unknown

Conditions: Breast Neoplasms

Treatments: Drug: 18F-FLT

Study type: Interventional

Funder types: Other

Identifiers

NCT01713049

201001043M

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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70 participants in 1 patient group

18F-FLT

Other group

Description:

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

Treatment:

Drug: 18F-FLT