- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01004666
Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions
Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions.
Aperçu de l'étude
Statut
Description détaillée
Recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in Mayo Clinic, Rochester, USA. Molecular Breast Imaging (MBI), which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions > 5 mm in diameter and 69% for tumors smaller than 5mm.
In Israel , genetic high- risk for breast cancer is highly relevant. We will offer the new imaging technology, to a wide patients population/group from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Therefore this stage will include:
- Women with equivocal findings on Mammography, US and/or MRI
- Women with discrepancy between CBE(clinical breast examination)and breast imaging
- Women with dense breast
- Women in high risk for Breast Cancer
Before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc.
The images will be correlated with other imaging tests including mammography, US and MRI. We will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams.
This phase will include 500 women.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Tel Aviv, Israël, 64239
- Recrutement
- Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
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Chercheur principal:
- Einat Even-Sapir, MD, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age over 25.
- Equivocal breast lesions.
- Dense breast tissue.
- High-risk for breast cancer
Exclusion Criteria:
- Age under 25.
- Pregnancy.
- Patients unable to understand and sign an informed consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Women with equivocal findings on Mammography, US and/or MRI
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Discrepancy between clinical examination and imaging
Women with discrepancy between clinical examination and breast imaging
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Women with dense breast
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Women in high risk for Breast Cancer
Women in high risk for Breast Cancer.
Including patients with genetic high risk and/or strong family history.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Detection of unexpected malignant lesions. Ruling out malignant lesions in case of equivocal lesions identified by clinical examination, mammography, US and/or MRI.
Délai: 6 mounth post scintigraphy
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6 mounth post scintigraphy
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Hruska CB, Phillips SW, Whaley DH, Rhodes DJ, O'Connor MK. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. AJR Am J Roentgenol. 2008 Dec;191(6):1805-15. doi: 10.2214/AJR.07.3693.
- Hruska CB, Boughey JC, Phillips SW, Rhodes DJ, Wahner-Roedler DL, Whaley DH, Degnim AC, O'Connor MK. Scientific Impact Recognition Award: Molecular breast imaging: a review of the Mayo Clinic experience. Am J Surg. 2008 Oct;196(4):470-6. doi: 10.1016/j.amjsurg.2008.06.005. Epub 2008 Aug 23.
- Hruska CB, O'Connor MK. Quantification of lesion size, depth, and uptake using a dual-head molecular breast imaging system. Med Phys. 2008 Apr;35(4):1365-76. doi: 10.1118/1.2885371.
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
- TASMC-09-EE-0192-CTIL
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