- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01898533
Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding (BOLD)
A Pilot Study of the Feasibility of Blood Oxygenation Level-Dependent Contrast ( BOLD) Breast MRI Induced by Breath- Holding
In this study, investigators intend to measure changes in BOLD contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. This study will provide the preliminary data and experience needed to successfully apply BOLD to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. The current study has the following objectives:
- To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.
- To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27710
- Duke University Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria: • Post-operative patients who are undergoing planning for future whole breast radiation therapy may be included in the study
- Female
- Age ≥18
- Negative serum pregnancy test for women of child bearing potential
- Signed study-specific informed consent
Exclusion Criteria:
- Unable to perform breath-holding of adequate duration.
- Unable to lie prone for approximately one hour during the study procedure
- Breast implants
- Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc.
- Positive serum pregnancy test
- Mastectomy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The change in BOLD contrast of the breasts and / or chest wall tissue will be measured by comparing breath hold sequences to normal breathing.
Tidsramme: During MRI approx 1 hour
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Subjects will be evaluated holding their breath and during normal breathing.
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During MRI approx 1 hour
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Feasibility as measured by a BOLD contrast signal in at least 30% of subjects
Tidsramme: During MRI approx one hour
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The imaging technique will be considered feasible if for any of the proposed imaging sequences, breath-holding induces a measurable (≥3× standard deviation of background) BOLD contrast signal in at least 30% of the subjects.
Contrast will be measured by comparing breath hold sequences to normal breathing.
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During MRI approx one hour
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Rachel Blitzblau, MD PhD, Duke University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Pro00046072
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