- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03573804
The Prone to Supine Breast MRI Trial
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
New Hampshire
-
Lebanon, New Hampshire, Vereinigte Staaten, 03756
- Dartmouth Hitchcock Medical Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Successful Segmentation of Supine MRI Images
Zeitfenster: 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.
|
30 minutes
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor
Zeitfenster: 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.
|
30 minutes
|
Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary
Zeitfenster: 30 minutes
|
Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.
|
30 minutes
|
Enhancement Quantification- Tumor-to-Background Ratio
Zeitfenster: 30 minutes
|
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
|
30 minutes
|
Time to Position and Obtain Supine Images
Zeitfenster: 30 Minutes
|
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.
|
30 Minutes
|
Overall Comfort for Prone and Supine Positions
Zeitfenster: Within 15 minutes of the scan
|
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.
|
Within 15 minutes of the scan
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Timothy B Rooney, MD, Dartmouth-Hitchcock Medical Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- D17168
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Brustkrebs
-
Novartis PharmaceuticalsAbgeschlossenMetastasierter Brustkrebs (MBC) | Locally Advance Breast Cancer (LABC)Vereinigtes Königreich, Spanien
-
BioNTech SESeventh Framework ProgrammeAbgeschlossenBrustkrebs (Triple Negative Breast Cancer (TNBC))Schweden, Deutschland
-
Filipa Lynce, MDAstraZeneca; Daiichi Sankyo, Inc.RekrutierungBrustkrebs | HER2-positiver Brustkrebs | Invasiver Brustkrebs | Entzündlicher Brustkrebs Stadium III | HER2 Low Breast AdenokarzinomVereinigte Staaten