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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90033
- USC Norris Comprehensive Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Undergo CEUS
Andre navn:
Undergo SWE
Andre navn:
Participant will receive contrast agent by intravenous administration
Andre navn:
Equipment used for SWE
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Model predicted treatment response for CEUS and SWE
Tidsramme: Up to 1 year
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Weighted Kappa will be used to assess the agreement.
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Up to 1 year
|
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Pathologically determined treatment response for CEUS and SWE
Tidsramme: Up to 1 year
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Weighted Kappa will be used to assess the agreement.
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Up to 1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Treatment response predicted by novel ultrasound techniques
Tidsramme: Up to 1 year
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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.
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Up to 1 year
|
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Treatment response predicted by CE MRI
Tidsramme: 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.
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Up to 1 year
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Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Linda Hovanessian-Larsen, University of Southern California
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1B-13-8 (Annen identifikator: USC Norris Comprehensive Cancer Center)
- P30CA014089 (U.S. NIH-stipend/kontrakt)
- NCI-2014-00085 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Legemiddel- og utstyrsinformasjon, studiedokumenter
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