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DLSCT for Breast Cancer Detection in Women With Dense Breasts (DECREAS)

5. januar 2022 opdateret af: Rijnstate Hospital

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Diagnostisk test: Dual-layer spectral computerized tomography (DLSCT)

Undersøgelsestype

Observationel

Tilmelding (Forventet)

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Carla M Meeuwis, MD,PhD
Telefonnummer: +31 26 378 8888
E-mail: cmeeuwis@rijnstate.nl

Studiesteder

Holland
- - Arnhem, Holland
    - Rekruttering
    - Rijnstate Hospital
    - Kontakt:
      
      Carla A Meeuwis, MD, PhD
      
      E-mail: cmeeuwis@rijnstate.nl

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

N/A

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Secondary care clinic

Beskrivelse

Inclusion Criteria:

Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
1. Tumors > 5 cm (= T3) or
2. Tumors with invasion of the skin or chest wall (= T4) or
3. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Visual tumor conspicuity Tidsramme: On the same 1 day as the regular PET-CT scan was performed	The conspicuity of tumors will be graded on a 4-point confidence scale	On the same 1 day as the regular PET-CT scan was performed
BI-RADS score Tidsramme: On the same 1 day as the regular PET-CT scan was performed	BI-RADS score according to the ACR BI-RADS lexicon	On the same 1 day as the regular PET-CT scan was performed

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Iodine enhancement Tidsramme: On the same 1 day as the regular PET-CT scan was performed	Iodine enhancement will be measured in Hounsfield Units (HU).	On the same 1 day as the regular PET-CT scan was performed
Iodine content Tidsramme: On the same 1 day as the regular PET-CT scan was performed	Iodine content will be measured mg/mL.	On the same 1 day as the regular PET-CT scan was performed

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Rijnstate Hospital

Efterforskere

Ledende efterforsker: Laura N Deden, Rijnstate Hospital
Ledende efterforsker: Maxime V.P. Schyns, MD, Rijnstate Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2022

Primær færdiggørelse (Forventet)

1. januar 2023

Studieafslutning (Forventet)