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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01713049

Enrollment

Registered

2012-10-24

Start date

2010-08-31

Completion date

2013-12-31

Last updated

2012-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

FLT PET, breast neoplasms, mammography, breast ultrasound

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.

Interventions

DRUG18F-FLT

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026