Clinical trial · Interventional
18F-FLT Positron Emission Tomography and Magnetic Resonance Imaging of the Breast
Integrative Diagnosis of 18F-FLT Positron Emission Tomography and Magnetic Resonance Imaging to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: a Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- diagnostic accuracy
- description
- diagnostic accuracy of PET and MRI for breast cancer diagnosis.
- interventionNames
- Drug: PET
Primary outcomes (1)
- measure
- diagnostic accuracy of 18F-FLT PET and MRI
- timeFrame
- 5 years
- description
- to measure diagnostic accuracy (sensitivity, specificity) of 18F-FLT PET and MRI for localized breast findings seen on mammography and breast ultrasound.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
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