Reduced Contrast Administration in Contrast-enhanced Spectral Mammography (CESM)

September 8, 2022 updated by: Maastricht University Medical Center

The optimal dose of iodine based contrast agents used in contrast-enhanced spectral mammography (CESM) is unknown. If CESM, performed with lower dose of iodine based contrast agent, visualizes a tumor comparable to CESM with regular dose of contrast agent, patients can receive less contrast agent for CESM in future and thereby risking less side effects of the contrast agent.

In order to study whether CESM remains unchanged at smaller amounts of contrast administration, a second CESM exam will be performed within one week of the first with a an alternative amount of contrast, it being either 80%, 60% or 40% of the original contrast dose. The settings of the CESM unit will remain unchanged.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center

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

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patient with histopathologically confirmed invasive breast cancer who recently underwent a clinical CESM exam without complications;
  • Treated with primary surgery;
  • Willing and able to undergo all study procedures;
  • Has personally provided written informed consent.
  • Age ≥ 18

Exclusion Criteria:

  • Pregnancy
  • Allergy for any of the ingredients of (Ultravist) contrast agent
  • Being unable to give informed consent in person
  • History of coronary arterial disease or unstable angina
  • Acute or chronic severe renal insufficiency

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arm A (40%)
Patients randomized in arm A will receive a second CESM exam with 40% of the initial dose of the contrast agent.
Procedure: CESM with a reduced dose of contrast agent
Experimental: arm B (60%)
Patients randomized in arm A will receive a second CESM exam with 60% of the initial dose of the contrast agent.
Procedure: CESM with a reduced dose of contrast agent
Experimental: arm C (80%)
Patients randomized in arm A will receive a second CESM exam with 80% of the initial dose of the contrast agent.
Procedure: CESM with a reduced dose of contrast agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accuracy of maximum tumor size measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations.
Time Frame: After completion of final patient inclusion (e.g. 1 year)
After completion of final patient inclusion (e.g. 1 year)

Secondary Outcome Measures

Outcome Measure
Time Frame
Enhancement measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations.
Time Frame: After completion of final patient inclusion (e.g. 1 year)
After completion of final patient inclusion (e.g. 1 year)

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Marc BI Lobbes, MD, PhD, Maastricht University Medical Center
  • Thiemo JA van Nijnatten, MD, PhD, Maastricht University Medical Center

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 (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 162048

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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