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

• Status: Unknown status
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Alovudine

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

Exclusion Criteria:

• 1) 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.

4) Women≦19 years old. 5) Past history of severe anaphylactoid reaction to MRI-contrast agent or 18F-FLT.

6) History of mechanical valve replacement, recent coronary artery stent placement, with pacemaker, aneurysmal clip, metallic endotracheal tube, or other procedures with metallic device application.

7) eGFR≦60ml/min/1.73m2. 8) History of acute renal failure, or renal dialysis.