DECREAS: DLSCT for Breast Cancer Detection in Women With Dense Breasts

Sponsor
Rijnstate Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05181059
Collaborator
(none)
14
1
12
1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Dual-layer spectral computerized tomography (DLSCT)

Study Design

Study Type:
Observational
Anticipated Enrollment :
14 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study
Actual Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Visual tumor conspicuity [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

  2. BI-RADS score [On the same 1 day as the regular PET-CT scan was performed]

    BI-RADS score according to the ACR BI-RADS lexicon

Secondary Outcome Measures

  1. Iodine enhancement [On the same 1 day as the regular PET-CT scan was performed]

    Iodine enhancement will be measured in Hounsfield Units (HU).

  2. Iodine content [On the same 1 day as the regular PET-CT scan was performed]

    Iodine content will be measured mg/mL.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rijnstate Hospital Arnhem Netherlands

Sponsors and Collaborators

  • Rijnstate Hospital

Investigators

  • Principal Investigator: Laura N Deden, Rijnstate Hospital
  • Principal Investigator: Maxime V.P. Schyns, MD, Rijnstate Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rijnstate Hospital
ClinicalTrials.gov Identifier:
NCT05181059
Other Study ID Numbers:
  • NL76792.091.21
First Posted:
Jan 6, 2022
Last Update Posted:
Jan 6, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2022