- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02814292
A Cost-Effective Handheld Breast Scanner for Use in Low Resource Environments: A Validation Study
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Phase 2A of this study is directed primarily at prototype development, creating, testing, and modifying a 4x4 finger array device with a small footprint that is battery powered and reliable. The testing in this phase is aimed at proving that modifications did not degrade the screening sensitivity of the original lab prototype.
Target enrollment is up to 100 patients to verify that the investigators have reproducible values in the same patient. Each breast will be evaluated and compared against each other whether it is considered normal or abnormal tissue. Data from patients both normal and abnormal regions will be compared and used to determine predictive value and accuracy in this prototype. The patient population will be women and men 18 years of age or older with symptomatic breast lump either by palpation or imaging.
Symptomatic individuals scheduled to undergo diagnostic exam will be recruited from all patients presenting for breast evaluations at Dr. Brooks clinical practices who meet all the inclusion and exclusion criteria. Consent will be obtained prior to any study related activities. The PEFS evaluation will be performed by a trained individual. Subjects will be scanned in supine position without breast immobilization - similar to ultrasound testing. The PEFS data is recorded and processed by an automated software algorithm and the results are displayed topographically on a breast-map with red areas showing positive findings and black areas showing negative findings. Quantitative data will be documented and analyzed for accuracy metrics. Results will not be given to subjects nor recorded in their medical records. Because this study is not a clinical utility study, results will have no effect on clinical care decisions. The PEFS evaluation may add between 10 and 30 minutes to the clinic visit. No imaging or pathology tests are being done for research purposes.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Pennsylvania Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
18 years or older
- women or men with symptomatic breast lump by palpation or imaging
Exclusion Criteria:
- under 18 years of age
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Estimate the sensitivity of the iBE device examinations using imaging results
Tidsramme: through study completion an average of 12 months
|
through study completion an average of 12 months
|
Estimate the specificity of the iBE device using imaging results
Tidsramme: through study completion an average of 12 months
|
through study completion an average of 12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 819121
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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