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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014