18F-FLT Positron Emission Tomography and Magnetic Resonance Imaging of the Breast

NCT01956890 | Unknown Phase 4

• 1 other identifier: 201102011MB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective study is aimed to evaluate the diagnostic effectiveness of 18F-FLT PET in differentiating benign nature from malignancy for lesions with suspicious or ambiguous findings on mammography or ultrasound; to determine whether 18F-FLT PET or MRI can increase the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy, and which (18F-FLT PET or MRI) reveals the higher diagnostic performance.

Conditions

Breast Cancer

Keywords

Breast neoplasms; PET; MRI

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy of 18F-FLT PET and MRI

  to measure diagnostic accuracy (sensitivity, specificity) of 18F-FLT PET and MRI for localized breast findings seen on mammography and breast ultrasound.

  5 years

Study Arms (1)

diagnostic accuracy

OTHER

diagnostic accuracy of PET and MRI for breast cancer diagnosis.

Drug: PET

Interventions

PET DRUG

18F-FLT PET and MRI of the breast

Also known as: 3'-deoxy-3'-[18F]fluorothymidine PET

diagnostic accuracy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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., and estimated GFR(eGFR)\>60ml/min/1.73m2.

You may not qualify if:

• \) Pregnant women or who are planning to be pregnant, or who are lactating. (Eligible women who are premenopausal with reproductive potential should receive urine pregnancy test before the MRI and PET. Women with a positive pregnancy test should be excluded from the study.) 2) Known cancers in other organs. 3) Women who are not able to cooperate with the PET/CT examination, or MRI examination.
• \) Women≦19 years old. 5) Past history of severe anaphylactoid reaction to MRI-contrast agent or 18F-FLT.
• \) History of mechanical valve replacement, recent coronary artery stent placement, with pacemaker, aneurysmal clip, metallic endotracheal tube, or other procedures with metallic device application.
• \) eGFR≦60ml/min/1.73m2. 8) History of acute renal failure, or renal dialysis.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jane Wang, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Wang, PhD

CONTACT

886223123456; hstjen@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2013
• First Posted: October 8, 2013
• Study Start: June 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

TW (1)