Evaluation of the High-resolution, Contrast Enhanced Low-dose Breast-CT

June 14, 2016 updated by: RWTH Aachen University
The aim of this study is the clinical establishment of a native and contrast-enhanced computer tomography of the breast. The early detection of breast cancer is still a great challenge. Even though the implementation of the digital mammography combined with the mandatory screening-programs lead to significant improvements, sensitivity and specificity of these examinations need to be clearly classified as improvable. Generally, it is stated that the necessary transit from 2-D projected images to 3-D tomography will be crucially advantageous as magnetic resonance imaging has already shown. Similar or even major advantages can be expected by new approaches regarding CT with very high local resolution, better than 100µm in 3D and lower dose, under 5 Milligray (mGy), as demanded for a screening. A device that meets these demands and is also applicable for dynamic scans after intravenous administration of a contrast agent, has been developed with the support by the European Union (EU), German Research Foundation (DFG) and Federal Ministry of Education and Research (BMBF). Publications on technical and experimental results are already available. An evaluation in the clinical use is missing yet. The primary aim of this study is to evaluate systematically the performance of the native and dynamic, contrast-enhanced CT of the breast.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

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

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Sub Study 1:

  • patients with mammographic or sonographic validated Breast Imaging Reporting and Data System (BI-RADS)-4 or BI-RADS-5-result or in BI-RADS-6-situation, i.e. with an already reliable carcinoma by punch biopsy, for which a clinical indication for a mamma-MRI consists.
  • Age >= 40
  • maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²)
  • normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks)
  • Persons which are able to give written consent and are aware of the nature, meaning and extent of the study
  • signed informed consent

Substudy 2:

  • patients with a doubtful and suspect clinical or mammographic or sonographic result (BI-RADS 3, 4a, 4b, 4c, 5) as well as patients with a reliable carcinoma by punch biopsy (BI-RADS 6), patients with high risk of breast cancer for which a clinical indication for a mamma-MRI consists.
  • Age >= 40
  • maintained renal function (MDRD with GFR >= 60 ml/min/1,73m²)
  • normal thyroid function, no clinical indication for an endocrine autonomy, normal TSH (not older than 8 weeks)
  • Persons which are able to give written consent and are aware of the nature, meaning and extent of the study
  • signed informed consent

Exclusion Criteria:

Substudy 1:

  • Pregnancy or lactation
  • Women with child-bearing potential without sufficient contraception
  • Age <40 years
  • Women with proven pathogenic Breast Cancer (BRCA) 1-mutation or heterozygote risk (>= 25%)
  • Hospitalization of patient ordered by the court or local authorities
  • Relationship of dependence or employment to sponsor or investigator

additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT

  • signs of a renal insufficiency (GFR < 60ml/min/1,73m²)
  • clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH)
  • Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine

Substudy 2:

  • Pregnancy or lactation
  • Women with child-bearing potential without sufficient contraception
  • Age <40 years
  • Women with proven pathogenic BRCA 1-mutation or heterozygote risk (>= 25%)
  • Hospitalization of patient ordered by the court or local authorities
  • Relationship of dependence or employment to sponsor or investigator

additionally the following criteria apply, if conducting the dynamic contrast-enhanced breast-CT:

  • end stage or advanced renal insufficiency
  • clinical signs or signs of the labor chemistry for endocrine autonomy (increase of TSH)
  • Patients with known allergies or intolerance reactions grade II or higher to contrast medium containing iodine

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Native and dynamic contrast-enhanced CT
Patients will undergo a native high-resolution and a dynamic contrast-enhanced CT, both sides respectively.
Device: Native and dynamic contrast-enhanced CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sub-Study 1: comparison of a-posteriori sensitivity using the native, contrast-enhanced or dynamic contrast-enhanced breast CT.
Time Frame: 2 years
By using the images diagnostic criteria for identification and characterization of the pathologic and physiologic changes of the female breast will be elaborated.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of biological value of the diagnosed carcinoma in dependence with its detection mode.
Time Frame: 2 years

Detection mode means the prospective visibility of a carcinoma in one or more independent imaging methods, respectively.

Biological value will be calculated by amount of high and intermediate grade vs. low grade lesions, status of Ki-67 values, distribution of luminal a, luminal b, Her2/neu and basal, distribution of receptor status
2 years
Substudy 2: sensitivity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
Time Frame: 2 years
2 years
Sub-study 2: specificity of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
Time Frame: 2 years
2 years
Substudy 2: Positive Predictive Value (PPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
Time Frame: 2 years
2 years
Substudy 2: Negative Predictive Value (NPV) of the native and the contrast-enhanced or dynamic contrast-enhanced high-resolution low-dose CT in comparison to the conventional examination procedures
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Christiane Kuhl, Univ.-Prof. Dr. med., Klinik für Diagnostische und Interventionelle Radiologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimate)

June 14, 2016

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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