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

Primary Purpose

Breast Neoplasms

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

18F-FLT

About this trial

This is an interventional diagnostic trial for Breast Neoplasms focused on measuring FLT PET, breast neoplasms, mammography, breast ultrasound

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women aged between 20 to 80 years
women who have localized findings on mammography and / or ultrasound and will receive biopsy.
The lesions on the conventional imaging measure >=1cm
WBC count >=3000/L, or platelet>=75,000/L
Liver function, AST or ALT < 78 U/L
Renal function, Creatinine < 2.0 mg/dl.The laboratory examinations should be performed within 4months before our study.

Exclusion Criteria:

Pregnant women or who are planning to be pregnant.
Known cancers in other organs.
Women who are not able to cooperate with the PET/CT examination.

Sites / Locations

Department of Medical Imaging NTUHRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

18F-FLT

Arm Description

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

Outcomes

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01713049

First Posted

October 21, 2012

Last Updated

October 23, 2012

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01713049

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Unknown status

Study Start Date

August 2010 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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. To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer diagnosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

Keywords

FLT PET, breast neoplasms, mammography, breast ultrasound

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

18F-FLT

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

18F-FLT

Other Intervention Name(s)

FLT

Intervention Description

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).

Primary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women aged between 20 to 80 years women who have localized findings on mammography and / or ultrasound and will receive biopsy. The lesions on the conventional imaging measure >=1cm WBC count >=3000/L, or platelet>=75,000/L Liver function, AST or ALT < 78 U/L Renal function, Creatinine < 2.0 mg/dl.The laboratory examinations should be performed within 4months before our study. Exclusion Criteria: Pregnant women or who are planning to be pregnant. Known cancers in other organs. Women who are not able to cooperate with the PET/CT examination.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jane Wang, PhD

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Medical Imaging NTUH

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jane Wang, MD, PhD

Phone

+886-2-23123456

Ext

65565

hstjen@yahoo.com.tw

12. IPD Sharing Statement

Learn more about this trial

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

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