- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02590458
Feasibility of Short Breast MRI (SBMRI) for Screening Patients at High Risk for Breast Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
If you agree to take part in this study, you will have the short breast MRI scan (the scan for research purposes) with contrast on a different day than your scheduled routine MRI screening scan with contrast. You will have your routine scan the first day and the research scan at least 1 day after. The research scan will take about 10 minutes to complete.
After your short breast MRI scan is completed, you will complete a questionnaire about your comfort level and experience of the research scan. It should take about 10 minutes to complete the questionnaire.
This is an investigational study. The short breast MRI is considered investigational.
Up to 200 participants will be enrolled in this study. All will be enrolled at MD Anderson.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiesteder
-
-
Texas
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Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 years and older female patients
- BMRI indication: high risk screening per ACS guidelines
- No contraindications to undergo MRI
- Creatinine </=1.3 and GFR> 40
- No requirement for sedation.
Exclusion Criteria:
- <18 years
- Male
- Is pregnant (confirmed by the patient as Imaging Clinic standard of care) or nursing mother
- Contraindication to Gd contrast agents
- Previous documented history of moderate to severe hypersensitivity to Gd contrast agents
- Contraindications to MRI
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Short Breast MRI (SBMRI)
Routine scheduled MRI with contrast performed on women at high risk of developing breast cancer.
One day after routine MRI, short breast MRI (SBMRI) with contrast performed.
After SBMRI, participant completes a questionnaire about their comfort level and experience of the research scan.
|
One day after routine MRI, short breast MRI (SBMRI) with contrast performed.
Scan will take about 10 minutes to complete.
Andre navne:
After SBMRI, participant completes a questionnaire about their comfort level and experience of the research scan.
It should take about 10 minutes to complete the questionnaire.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Sensitivity of SBMRI for Detecting Breast Cancer in High Risk Participants
Tidsramme: 1 day
|
Radiologists blinded to patient outcome review images from each study independently and rate the possibility of breast cancer using BI-RADS score.
BIRADS 0, 3,4, 5 considered positive, BIRADS 1 and 2 considered negative results for the analysis.
Each reader's score for a given case assessed both independently and on a separate session, as consensus.
|
1 day
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Marion E. Scoggins, MD, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
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 (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2015-0243
- NCI-2015-02031 (Registry Identifier: NCI CTRP)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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