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

Not Applicable

Terminated

• Conditions: Breast Neoplasm; Contrast-enhanced Spectral Mammography
• Interventions: Procedure: CESM with a reduced dose of contrast agent

• Registration Number: NCT03008031
• Lead Sponsor: Maastricht University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-28
• Study Start: 2017-01
• Study First Posted: 2017-01-02
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm A (40%)	CESM with a reduced dose of contrast agent	Patients randomized in arm A will receive a second CESM exam with 40% of the initial dose of the contrast agent.
arm C (80%)	CESM with a reduced dose of contrast agent	Patients randomized in arm A will receive a second CESM exam with 80% of the initial dose of the contrast agent.
arm B (60%)	CESM with a reduced dose of contrast agent	Patients randomized in arm A will receive a second CESM exam with 60% of the initial dose of the contrast agent.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands