- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00918788
Laser Spectroscopy of Breast Tissue Through a Needle Device
RATIONALE: Collecting and storing samples of breast tissue from patients who have undergone biopsy or surgery to test in the laboratory may help the study of cancer in the future.
PURPOSE: This laboratory study is looking at samples of breast tissue from women who have undergone breast biopsy or surgery.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
- To prove that optical spectra collected by inserting an optical fiber probe into breast tissue through a biopsy needle can be of adequate quality to render a spectroscopic diagnosis.
OUTLINE: Optical spectra are acquired from ex vivo samples of normal and malignant breast tissue using diffuse reflectance, fluorescence, and Raman spectroscopy. Tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle. After the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements. The biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., H&E staining and IHC). Additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results.
Medical records are reviewed to obtain information from the pathology report on patient demographics, pathological characteristics of the surgical specimen, and clinical indication for the surgical procedure.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44106-5065
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
DISEASE CHARACTERISTICS:
- Discarded normal and malignant breast tissue surgical specimens from women who have undergone excisional breast biopsy, lumpectomy, mastectomy, or breast-reduction surgery at the University Hospitals-Case Medical Center
- Hormone receptor status unknown
PATIENT CHARACTERISTICS:
- Menopausal status unknown
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Collection of optical spectra from normal and malignant breast tissue samples
Tidsramme: at time of excisional breast biopsy, lumpectomy, mastectomy or breast reduction surgery
|
at time of excisional breast biopsy, lumpectomy, mastectomy or breast reduction surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Maryann Fitzmaurice, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
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 (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CASE9107 (Annen identifikator: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH-stipend/kontrakt)
- CASE-9107-CC482 (Annen identifikator: Case Cancer IRB)
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