Comparing the Performance of Automated Breast Ultrasonography to Hand-Held Whole Breast Ultrasonography in Breast Cancer Treatment Response Assessment
24. maj 2022 opdateret af: M.D. Anderson Cancer Center
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
This study compares the performance of automated breast ultrasonography and conventional hand-held whole breast ultrasonography when checking for response to breast cancer treatment.
Breast ultrasonography is operator dependent and time-intensive.
Automated breast ultrasonography scanners were developed to allow standardization of ultrasound scanning and scanning to be performed by any technologist, with or without previous ultrasound experience, without physician involvement.
This study may validate the use of the automated breast ultrasonography.
Studieoversigt
Status
Trukket tilbage
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with breast cancer or suspicion of breast cancer seen in MD Anderson Breast imaging clinic at the Texas Medical Center (TMC)
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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).
|
Undergo ABUS
Andre navne:
Undergo WBUS
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area under the receiver operating characteristic (ROC) curve
Tidsramme: through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Tumor volume
Tidsramme: through study completion, an average of 1 year
|
Will compute the intraclass correlation coefficient for each method along with 95% confidence intervals and then compare these estimates.
|
through study completion, an average of 1 year
|
|
Relative tumor volume change
Tidsramme: through study completion, an average of 1 year
|
Will compute the relative change in tumor volume for ABUS and WBUS and assess their agreement using the Bland-Altman approach.
|
through study completion, an average of 1 year
|
|
Sensitivity
Tidsramme: through study completion, an average of 1 year
|
The cutoff point will be determined using Youden Index, i.e., the point that maximize (sensitivity specificity).
|
through study completion, an average of 1 year
|
|
Specificity
Tidsramme: through study completion, an average of 1 year
|
The cutoff point will be determined using Youden Index, i.e., the point that maximize (sensitivity specificity).
|
through study completion, an average of 1 year
|
|
Positive predictive value
Tidsramme: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
|
|
Negative predictive value
Tidsramme: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Monica L Huang, M.D. Anderson Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
29. november 2021
Primær færdiggørelse (Faktiske)
29. november 2021
Studieafslutning (Faktiske)
29. november 2021
Datoer for studieregistrering
Først indsendt
30. juli 2021
Først indsendt, der opfyldte QC-kriterier
6. august 2021
Først opslået (Faktiske)
16. august 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. maj 2022
Sidst verificeret
1. maj 2022
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2020-0831 (M D Anderson Cancer Center)
- NCI-2021-05381 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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