DLSCT for Breast Cancer Detection in Women With Dense Breasts

NCT05181059 | Unknown

• 1 other identifier: NL76792.091.21
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Breast Density; Radiographic Image Interpretation, Computer-Assisted

Outcome Measures

Primary Outcomes (2)

• Visual tumor conspicuity

  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

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

  On the same 1 day as the regular PET-CT scan was performed

Secondary Outcomes (2)

• Iodine enhancement

  On the same 1 day as the regular PET-CT scan was performed

• Iodine content

  On the same 1 day as the regular PET-CT scan was performed

Interventions

Dual-layer spectral computerized tomography (DLSCT) DIAGNOSTIC_TEST

Contrast enhanced DLSCT scan using a 128-slice dual-layer detector (IQon Spectral CT, Philips Health Systems) will be performed. Patients will be placed in prone position during the DLSCT scan in order to improve the visualisation of breast tissue and comparability with MRI images. During the examination we will administer a nonionic low-osmolar iodinated contrast agent (Optiray©) in order to visualise tumor angiogenesis.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Secondary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate Hospital

Arnhem, Netherlands

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura N Deden

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

• Maxime V.P. Schyns, MD

  Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla M Meeuwis, MD,PhD

CONTACT

+31 26 378 8888; cmeeuwis@rijnstate.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 6, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: January 6, 2022

Record last verified: 2022-01

Locations

NL (1)