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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01713049
• Other study ID #: 201001043M
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2012
• Last updated: October 23, 2012
• Start date: August 2010
• Est. completion date: December 2013

Study information

• Verified date: August 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• 18F-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).

Locations

Country	Name	City	State
Taiwan	Department of Medical Imaging NTUH	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes