Surveillance de la chimiothérapie néoadjuvante du cancer du sein à l'aide de l'estimation de la pression assistée par subharmonique 3D
This phase II/III trial studies if contrast-enhanced ultrasounds using a contrast dye, perflutren lipid microspheres (Definity), can predict the response to chemotherapy by estimating the pressure in the cancer in patients with breast cancer that has spread to nearby tissues and lymph nodes (locally advanced). The efficacy of cancer therapy is affected by the pressure in the cancer. Definity is a contrast dye used to create better images during ultrasounds. The purpose of this trial is to determine if a special kind of ultrasound, called contrast-enhanced ultrasound, an experimental imaging test, can detect pressures in cancer to determine the response to neoadjuvant chemotherapy in patients with breast cancer.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVE:
I. To apply and evaluate a novel biomarker from 3-dimensional subharmonic aided pressure estimation (3D SHAPE) to predict neoadjuvant chemotherapy (NAC) response in patients with breast cancer.
SECONDARY OBJECTIVE:
I. To assess whether the accuracy of 3D SHAPE for predicting locally advanced breast cancer (LABC) NAC response varies with breast cancer subtype.
OUTLINE:
Patients undergo contrast-enhanced ultrasound (CEUS) and receive perflutren lipid microspheres intravenously (IV) over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC.
After completion of study, patients are followed up at the completion of NAC.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
- Phase 3
Contacts et emplacements
Lieux d'étude
-
-
Minnesota
-
Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19107
- Thomas Jefferson University Hospital
-
-
Texas
-
Dallas, Texas, États-Unis, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- At least 21 years old
- Be diagnosed with breast cancer (T1 or greater LABC, any N and M0)
- Be scheduled for neoadjuvant chemotherapy
- Be medically stable
- Be conscious and able to comply with study procedures
- If a female of child-bearing potential, must have a negative urine pregnancy test
Exclusion Criteria:
-
Males
-
Females who are pregnant or nursing
-
Patients with other primary cancers requiring systemic treatment
-
Patients with any distal metastatic disease
-
Patients undergoing neoadjuvant endocrine therapy
-
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
- Patients on life support or in a critical care unit;
- Patients with unstable occlusive disease (e.g., crescendo angina);
- Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia;
- Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] Class IV);
- Patients with recent cerebral hemorrhage;
- Patients who have undergone surgery within 24 hours prior to the study sonographic examination
-
Patients with known hypersensitivity or allergy to any component of Definity
-
Patients with unstable cardiopulmonary conditions or respiratory distress syndrome
-
Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli
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 |
|---|---|
|
Expérimental: Diagnostic (CEUS, Definity)
Patients undergo CEUS and receive perflutren lipid microspheres IV over 10-15 minutes before NAC, after 10% of NAC, and after 30% of NAC. Patients also undergo unenhanced baseline ultrasound imaging before NAC, after 10% of NAC, after 30% of NAC, and after 100% of NAC |
Undergo CEUS
Autres noms:
Given IV
Autres noms:
Undergo unenhanced baseline ultrasound |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Calculation of tumor volume changes with neoadjuvant chemotherapy (NAC)
Délai: Up to study completion (48 months)
|
3-dimensional (3D) tumor measurements over the three ultrasound exams will be recorded for each subject to calculate tumor volume changes with NAC. The tumor volume change during the therapy will be compared to imaging (magnetic resonance imaging or ultrasound) and pathologic response as well as to the corresponding 3D subharmonic aided pressure estimation (SHAPE) results. |
Up to study completion (48 months)
|
|
Prediction of the patients' clinical and pathological response
Délai: Up to study completion (48 months)
|
The SHAPE results from three time points (i.e. before, 10% completion, and 30% completion of NAC) will be modeled for predicting the patients' clinical response as well as pathological response using longitudinal logistic regression with adjustment for correlated observations over time by generalized linear mixed effects or generalized estimating equations (GEE) modeling. |
Up to study completion (48 months)
|
|
The ability of the SHAPE method to distinguish responders from non-responders
Délai: Up to study completion (48 months)
|
Will also be compared using receiver operating characteristic analysis to develop thresholds for decision-making based on balancing sensitivity and specificity. |
Up to study completion (48 months)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Accuracy of the 3D SHAPE for predicting locally advanced breast cancer NAC response varies with breast cancer subtype
Délai: Up to study completion (48 months)
|
The variation of the accuracies of the SHAPE results by breast cancer subtypes will be reported. The generalized linear mixed effects or GEE modeling will be stratified by breast cancer subtype and also extended to include modeling of breast cancer subtype as a main effect and as an interaction effect with SHAPE. |
Up to study completion (48 months)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kibo Nam, MD, Thomas Jefferson University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
- 20F.259
- R37CA234428 (Subvention/contrat des NIH des États-Unis)
- JT 14825 (Autre identifiant: JeffTrial Number)
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .