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


N/A
20 Years
80 Years
Open (Enrolling)
Female
Breast Neoplasms

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Jane Wang, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Taiwan University Hospital

Authority:

United States: Food and Drug Administration

Study ID:

201001043M

NCT ID:

NCT01713049

Start Date:

August 2010

Completion Date:

December 2013

Related Keywords:

  • Breast Neoplasms
  • FLT PET
  • breast neoplasms
  • mammography
  • breast ultrasound
  • Breast Neoplasms
  • Neoplasms

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