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

NCT03008031 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-09-13

No results posted yet for this study

Summary

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.

Conditions

  • Breast Neoplasm
  • Contrast-enhanced Spectral Mammography

Interventions

PROCEDURE

CESM with a reduced dose of contrast agent

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Marc BI Lobbes, MD, PhD · Maastricht University Medical Center

  • Thiemo JA van Nijnatten, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03008031 on ClinicalTrials.gov