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

Breast Neoplasm Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03008031
• Other study ID #: 162048
• Status: Terminated
• Phase: N/A
• Start date: January 2017
• Est. completion date: April 2020

Study information

• Verified date: September 2022
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms
• Contrast-enhanced Spectral Mammography

Intervention

Procedure:
• CESM with a reduced dose of contrast agent

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		After completion of final patient inclusion (e.g. 1 year)
Secondary	Enhancement measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations.		After completion of final patient inclusion (e.g. 1 year)