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

NCT ID: NCT03008031

Last Updated: 2022-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2020-04-30

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.

Conditions

Breast Neoplasm; Contrast-enhanced Spectral Mammography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

arm A (40%)

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

Group Type: EXPERIMENTAL

CESM with a reduced dose of contrast agent

Intervention Type: PROCEDURE

arm B (60%)

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

Group Type: EXPERIMENTAL

CESM with a reduced dose of contrast agent

Intervention Type: PROCEDURE

arm C (80%)

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

Group Type: EXPERIMENTAL

CESM with a reduced dose of contrast agent

Intervention Type: PROCEDURE

Interventions

CESM with a reduced dose of contrast agent

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc BI Lobbes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Thiemo JA van Nijnatten, MD, PhD

Role:

Maastricht University Medical Center

Locations

Maastricht University Medical Center

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

162048

Identifier Type: -

Identifier Source: org_study_id