NCT01713049

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 24, 2012

Status Verified

August 1, 2010

Enrollment Period

2.3 years

First QC Date

October 21, 2012

Last Update Submit

October 23, 2012

Conditions

Breast Neoplasms

Keywords

FLT PETbreast neoplasmsmammographybreast ultrasound

Outcome Measures

Primary Outcomes (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.

Study Arms (1)

18F-FLT

OTHER

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

Drug: 18F-FLT

Interventions

18F-FLTDRUG

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).

Also known as: FLT
18F-FLT

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Imaging NTUH

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

alovudine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jane Wang, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Taiwan University Hospital

Study Record Dates

First Submitted

October 21, 2012

First Posted

October 24, 2012

Study Start

August 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

October 24, 2012

Record last verified: 2010-08

Locations

TW(1)