- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01956890
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
Aperçu de l'étude
Description détaillée
It has been reported that PET (Positron Emission Tomography) scan is also useful in diagnosing breast cancer. 18F-fluorodeoxyglucose (18F-FDG), which based on glucose metabolism for the determination of malignancy, is the most popular PET tracer at present. However, 18F-FDG is not tumor specific. Benign inflammatory lesions may also demonstrate increase in 18F-FDG uptake. On the other hand, low grade malignancy may have low 18F-FDG concentration. Recently, 18F-3'-fluoro-3'-deoxy-L-thymidine (18F-FLT), a radiolabelled analog of thymidine, has been used in imaging cell proliferation and monitoring of treatment effects for breast cancer patients. 18F-FLT is believed to be more specific than 18F-FDG for breast cancer diagnosis and may provide the underlined physiological and molecular manifestations of breast lesions in addition to anatomical manifestations from mammography, ultrasound or MRI. Yet, its potential role in differentiation of ambiguous or suspicious lesions found on conventional imaging, such like mammography or ultrasound, has not been reported. We have had an ongoing preliminary study regarding breast lesion diagnosis using 18F-FLT PET, with an overall sensitivity 100% and specificity 92.7% in this dataset (from 2010 August to 2010 December, 19 lesions from 8 women with correlation with biopsy and clinical outcome).
On the other hand, the molecular subtypes of breast cancer, including ER (Estrogen receptor), PR (Progesterone receptor), HER2 (Human epidermal growth factor receptor 2) are associated with treatment planning and prediction of clinical outcome of breast cancer. There have been documented reports regarding the relation of mammography, DCE MRI, 18F-FDG PET to ER, PR, HER2 status of breast cancers. But the association of proton MRS, DWI and 18F-FLT PET with ER, PR, HER2 status was seldom reported.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Taipei, Taïwan, 100
- Recrutement
- National Taiwan University Hospital
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Contact:
- Jane Wang, PhD
- Numéro de téléphone: 65565 886223123456
- E-mail: hstjen@yahoo.com.tw
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Chercheur principal:
- Jane Wang, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Autre: diagnostic accuracy
diagnostic accuracy of PET and MRI for breast cancer diagnosis.
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18F-FLT PET and MRI of the breast
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
diagnostic accuracy of 18F-FLT PET and MRI
Délai: 5 years
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to measure diagnostic accuracy (sensitivity, specificity) of 18F-FLT PET and MRI for localized breast findings seen on mammography and breast ultrasound.
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5 years
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 201102011MB
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