- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02067884
Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery
Real Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (NAC).
II. To assess the agreement between CEUS based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
III. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of NAC.
IV. To assess the agreement between shear wave elastography (SWE) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
SECONDARY OBJECTIVES:
I. To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3 weeks following initiation of NAC), in accurately predicting the pathologically determined tumor response.
II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables.
OUTLINE:
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 1
Kontakte und Standorte
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90033
- USC Norris Comprehensive Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Women with histologically confirmed breast cancer (by core needle biopsy)
- Women with >= 2 cm clinically or radiologically measureable breast cancer
- Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
- Women competent to sign study specific written Informed Consent
- Women willing to comply with protocol requirements
Exclusion Criteria:
- Women who are pregnant
- Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis
- Women who have had a prior history of breast cancer in the same breast
- Women with known cardiac shunt, pulmonary hypertension or hypersensitivity to perflutren agent
- Women who cannot consent for themselves
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Diagnostic (CEUS, SWE)
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
|
Undergo CEUS
Andere Namen:
Undergo SWE
Andere Namen:
Participant will receive contrast agent by intravenous administration
Andere Namen:
Equipment used for SWE
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Model predicted treatment response for CEUS and SWE
Zeitfenster: Up to 1 year
|
Weighted Kappa will be used to assess the agreement.
|
Up to 1 year
|
|
Pathologically determined treatment response for CEUS and SWE
Zeitfenster: Up to 1 year
|
Weighted Kappa will be used to assess the agreement.
|
Up to 1 year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Treatment response predicted by novel ultrasound techniques
Zeitfenster: Up to 1 year
|
Weighted Kappa will be used to assess the agreement.
Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.
|
Up to 1 year
|
|
Treatment response predicted by CE MRI
Zeitfenster: Up to 1 year
|
Weighted Kappa will be used to assess the agreement.
Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.
|
Up to 1 year
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Linda Hovanessian-Larsen, University of Southern California
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1B-13-8 (Andere Kennung: USC Norris Comprehensive Cancer Center)
- P30CA014089 (US NIH Stipendium/Vertrag)
- NCI-2014-00085 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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