Text Size

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

This study is currently recruiting participants.
Verified August 2010 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01713049
First received: October 21, 2012
Last updated: October 23, 2012
Last verified: August 2010
History of Changes
  Purpose

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


Condition Intervention
Breast Neoplasms
 Drug: 18F-FLT

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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. [ Time Frame: The biopsy procedures will be scheduled as soon as possible and should be finished within 2 months after 18F-FLT PET. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: FLT

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.
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01713049

Locations
Taiwan
Department of Medical Imaging NTUH Recruiting
Taipei, Taiwan, 100
Contact: Jane Wang, MD, PhD     +886-2-23123456 ext 65565     hstjen@yahoo.com.tw    
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jane Wang, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01713049     History of Changes
Other Study ID Numbers: 201001043M
Study First Received: October 21, 2012
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by National Taiwan University Hospital:
FLT PET
breast neoplasms
mammography
breast ultrasound

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
 Alovudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013