- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03573804
The Prone to Supine Breast MRI Trial
Studieoversigt
Detaljeret beskrivelse
The purpose of this study is to find out whether additional MRI images taken with patients in a different position after completing a standard MRI are of sufficient quality to allow a radiologist to identify the edges of the tumor.
These additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.The information gathered in this study will make it more feasible to use a new device called the "breast cancer locator" to help surgeons more accurately remove breast cancers.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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New Hampshire
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Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Age > 18 years.
- Female gender.
- Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
- Tumor size at least 1 cm in diameter as visualized on mammogram or US.
- A diagnostic breast MRI is considered to be clinically indicated.
- Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
Exclusion Criteria:
- Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
- Severe claustrophobia.
- Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2).
- History of median sternotomy.
- Pregnancy. Patient attestation that they are not pregnant will be acceptable.
- Patients who have received neoadjuvant chemotherapy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Prone to Supine MRI
The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI.
Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI.
Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition.
Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.
|
The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI.
Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI.
Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition.
Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Successful Segmentation of Supine MRI Images
Tidsramme: 30 minutes
|
Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.
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30 minutes
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor
Tidsramme: 30 minutes
|
Compare the signal intensity with that obtained at tumor location on the prone and supine imaging.
The amount of enhancement at the tumor site = segmented tumor.
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30 minutes
|
Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary
Tidsramme: 30 minutes
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Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.
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30 minutes
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Enhancement Quantification- Tumor-to-Background Ratio
Tidsramme: 30 minutes
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Mean MRI signal of the segmented tumor divided by the mean MRI signal of the surrounding tissue which has an equal volume to the tumor.
The difference between tumor and benign breast tissue is the tumor-to-background ratio
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30 minutes
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Time to Position and Obtain Supine Images
Tidsramme: 30 Minutes
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Calculate the additional time needed to obtain supine MRI images.
After the completion of Prone imaging, the patient was removed from the MRI, turned over to the supine position, new coils placed, and returned to the MRI for additional imaging.
The aggregate time to accomplish these tasks are noted in minutes.
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30 Minutes
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Overall Comfort for Prone and Supine Positions
Tidsramme: Within 15 minutes of the scan
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Quantify the perceived comfort level of the prone and supine MRI as reported by participants.
A single question using a Likert scale was was used.
The scale range was 0 to 5, where 0 = no pain, completely comfortable and 5 = considerable discomfort.
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Within 15 minutes of the scan
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Timothy B Rooney, MD, Dartmouth-Hitchcock Medical Center
Publikationer og nyttige links
Generelle publikationer
- Barth RJ Jr, Krishnaswamy V, Paulsen KD, Rooney TB, Wells WA, Rizzo E, Angeles CV, Marotti JD, Zuurbier RA, Black CC. A Patient-Specific 3D-Printed Form Accurately Transfers Supine MRI-Derived Tumor Localization Information to Guide Breast-Conserving Surgery. Ann Surg Oncol. 2017 Oct;24(10):2950-2956. doi: 10.1245/s10434-017-5979-z. Epub 2017 Aug 1.
- Leong CS, Daniel BL, Herfkens RJ, Birdwell RL, Jeffrey SS, Ikeda DM, Sawyer-Glover AM, Glover GH. Characterization of breast lesion morphology with delayed 3DSSMT: an adjunct to dynamic breast MRI. J Magn Reson Imaging. 2000 Feb;11(2):87-96. doi: 10.1002/(sici)1522-2586(200002)11:23.0.co;2-e.
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 (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D17168
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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