- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05181059
DLSCT for Breast Cancer Detection in Women With Dense Breasts (DECREAS)
Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study
The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.
Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Carla M Meeuwis, MD,PhD
- Telefonnummer: +31 26 378 8888
- E-post: cmeeuwis@rijnstate.nl
Studiesteder
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Arnhem, Nederland
- Rekruttering
- Rijnstate Hospital
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Ta kontakt med:
- Carla A Meeuwis, MD, PhD
- E-post: cmeeuwis@rijnstate.nl
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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:
Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
- Tumors > 5 cm (= T3) or
- Tumors with invasion of the skin or chest wall (= T4) or
- Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3)
- Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon
Exclusion Criteria:
- History of allergic reactions to iodinated contrast agents
- Pregnancy or breast feeding
- Treatment of thyroid disease with radioactive iodine
- Use of metformin
- Creatinine clearance < 45 ml/min
- Chronic or acutely worsening renal disease
- Patients who are declared incompetent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Visual tumor conspicuity
Tidsramme: On the same 1 day as the regular PET-CT scan was performed
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The conspicuity of tumors will be graded on a 4-point confidence scale
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On the same 1 day as the regular PET-CT scan was performed
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BI-RADS score
Tidsramme: On the same 1 day as the regular PET-CT scan was performed
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BI-RADS score according to the ACR BI-RADS lexicon
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On the same 1 day as the regular PET-CT scan was performed
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Iodine enhancement
Tidsramme: On the same 1 day as the regular PET-CT scan was performed
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Iodine enhancement will be measured in Hounsfield Units (HU).
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On the same 1 day as the regular PET-CT scan was performed
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Iodine content
Tidsramme: On the same 1 day as the regular PET-CT scan was performed
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Iodine content will be measured mg/mL.
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On the same 1 day as the regular PET-CT scan was performed
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Laura N Deden, Rijnstate Hospital
- Hovedetterforsker: Maxime V.P. Schyns, MD, Rijnstate Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NL76792.091.21
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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