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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01713049
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arm: 1
• Duration (Months): 40
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasms	Drug: 18F-FLT	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Use of 18F-FLT Positron Emission Tomography to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: A Pilot Study
• Study Start Date: Aug 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2012
• Anticipated Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 18F-FLT 18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound.	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).; Other Names: FLT

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medical Imaging NTUH	Taipei		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Jane Wang, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital, National Taiwan University Hospital, National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT01713049
• Other Study ID Numbers: 201001043M
• First Posted: Oct 24, 2012
• Last Update Posted: Oct 24, 2012
• Last Verified: Aug 1, 2010

• Keywords provided by National Taiwan University Hospital, National Taiwan University Hospital, National Taiwan University Hospital: FLT PET; breast neoplasms; mammography; breast ultrasound
• Additional relevant MeSH terms: Breast Neoplasms; Alovudine

Study Results

No Results Posted as of Oct 24, 2012