- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05005936
Comparing the Performance of Automated Breast Ultrasonography to Hand-Held Whole Breast Ultrasonography in Breast Cancer Treatment Response Assessment
Comparing the Performance of Automated Breast Ultrasonography (ABUS) to Hand-Held Breast Ultrasonography (WBUS) in Breast Cancer Treatment Response Assessment in a Tertiary Cancer Center: A Prospective Study
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVE:
I. To estimate and compare the accuracy of automated breast ultrasonography (ABUS) and hand-held whole breast ultrasonography (WBUS) in predicting pathology complete response (pCR) with relative tumor volume change, using the receiver operating characteristic (ROC) curve analysis.
SECONDARY OBJECTIVES:
I. To evaluate the reproducibility of tumor volume measurements obtained by ABUS and handheld WBUS, respectively, using data collected at baseline for initial staging.
II. To assess the agreement in relative tumor volume change (RC) (end-of-treatment versus [vs.] pre-treatment) between ABUS and WBUS.
III. To estimate and compare the following diagnostic measures for ABUS and WBUS: sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
OUTLINE:
Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment).
Type d'étude
Contacts et emplacements
Lieux d'étude
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Texas
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Houston, Texas, États-Unis, 77030
- M D Anderson Cancer Center
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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:
- The subjects to be studied will include patients seen in MD Anderson Breast imaging clinic at the Texas Medical Center (TMC)
- With breast cancer or suspicion of breast cancer
- Male or female who is older than 18 years of age
- Of any race
- Who consent to obtain technologist performed breast ultrasound and automated breast ultrasound
- English and non-English speakers (with language interpreter to assist in translation for non-English speakers)
Exclusion Criteria:
- Patient who is less than 18 years of age
- Imaging obtained outside of MD Anderson TMC
- Surgery pathology from outside of MD Anderson will be excluded from this study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Ancillary-Correlative (ABUS, WBUS)
Patients undergo ABUS over 15 minutes followed by WBUS over 30 minutes at baseline, mid-treatment and pre-surgery (end of treatment).
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Undergo ABUS
Autres noms:
Undergo WBUS
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Area under the receiver operating characteristic (ROC) curve
Délai: through study completion, an average of 1 year
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Will compute relative tumor volume change for both automated breast ultrasonography (ABUS) and hand-held whole breast ultrasonography (WBUS) and estimate pathology complete response ROC curves for each.
Will estimate the areas under the ROC curves along with 95% confidence intervals and then compare the values statistically.
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through study completion, an average of 1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Tumor volume
Délai: through study completion, an average of 1 year
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Will compute the intraclass correlation coefficient for each method along with 95% confidence intervals and then compare these estimates.
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through study completion, an average of 1 year
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Relative tumor volume change
Délai: through study completion, an average of 1 year
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Will compute the relative change in tumor volume for ABUS and WBUS and assess their agreement using the Bland-Altman approach.
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through study completion, an average of 1 year
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Sensitivity
Délai: through study completion, an average of 1 year
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The cutoff point will be determined using Youden Index, i.e., the point that maximize (sensitivity specificity).
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through study completion, an average of 1 year
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Specificity
Délai: through study completion, an average of 1 year
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The cutoff point will be determined using Youden Index, i.e., the point that maximize (sensitivity specificity).
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through study completion, an average of 1 year
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Positive predictive value
Délai: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
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Negative predictive value
Délai: through study completion, an average of 1 year
|
through study completion, an average of 1 year
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Monica L Huang, M.D. Anderson Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2020-0831 (M D Anderson Cancer Center)
- NCI-2021-05381 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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Essais cliniques sur Carcinome du sein
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AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie