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

January 5, 2022 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Secondary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual tumor conspicuity
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iodine enhancement
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rijnstate Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

December 16, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

January 6, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL76792.091.21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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