- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00957099
Comparison Study of Breast Computed Tomography (CT) With Magnetic Resonance Imaging (MRI)
A Comparison Study of Contrast Enhanced Breast CT With MRI On Known Malignancies For Detection of Multifocal/Multicentric Disease
Lay Summary
After patients are diagnosed with breast cancer, they undergo breast magnetic resonance (MR) imaging to determine if the cancer is located in more than one place in the breast. Breast MR imaging is a good option for this test because it has very high sensitivity (catches almost all breast tumors). However, breast MR is slow: it takes about two minutes to acquire one image, and is very low resolution. The points that make up the breast MR image are around 1 to 3 mm in size.
Dedicated breast computed tomography (or breast CT), a new way of imaging the breast, has been introduced in the last few years. Breast CT is an x-ray exam that uses 3D imaging to show the breast in its real three dimensional shape. Combined with the use of special chemicals called iodine contrast enhancement, breast CT can provide images of both the anatomy and the blood flow in the breast. As opposed to breast MR, breast CT is very fast. An image can be taken in 10 seconds, and has very high resolution. The points in the breast CT image are only 0.14 mm in size. The investigators propose to use breast CT instead of breast MR imaging to determine if the patient's breast cancer is located in more than one place. This is the first time anybody has proposed to use breast CT for this, so the investigators aim to test the feasibility of the idea with only 6 patients.
Since the patients will undergo breast MR as part of the standard of care, the investigators will be able to compare the breast CT images to the current standard, breast MR. This work will lay a foundation for performing this very important test before breast cancer treatment planning with a new, fast, high resolution imaging method, breast CT.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Emory University Hospital Breast Imaging Center
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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
3.1 Eligibility Criteria All subjects will be women at least 35 years of age that have been diagnosed with breast cancer and have undergone breast MR imaging for detection of multifocal/multicentric disease.
3.2 Ineligibility Criteria
- Subject does not meet any of the inclusion criteria
- Women with suspected or confirmed pregnancy
- Women who have had bilateral mastectomy
- Women who are very frail and unable to cooperate
- Women who cannot give informed consent
- Male subjects
- Women with implants
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Imaging
Women diagnosed with breast cancer having pre-treatment MRI for spread of disease
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Comparison of staging accuracy
Tidsramme: After biopsy
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After biopsy
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ioannis Sechopoulos, PhD, Emory University
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
- IRB00014357
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