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

Maastricht University Medical Centre (MUMC)

Status: Terminated

Conditions: Breast Neoplasm; Contrast-enhanced Spectral Mammography

Treatments: Procedure: CESM with a reduced dose of contrast agent

Study type: Interventional

Funder types: Other

Identifiers

NCT03008031

162048

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 3 patient groups

arm A (40%)

Experimental group

Description:

Patients randomized in arm A will receive a second CESM exam with 40% of the initial dose of the contrast agent.

Treatment:

Procedure: CESM with a reduced dose of contrast agent

arm B (60%)

Experimental group

Description:

Patients randomized in arm A will receive a second CESM exam with 60% of the initial dose of the contrast agent.

Treatment:

Procedure: CESM with a reduced dose of contrast agent

arm C (80%)

Experimental group

Description:

Patients randomized in arm A will receive a second CESM exam with 80% of the initial dose of the contrast agent.

Treatment:

Procedure: CESM with a reduced dose of contrast agent