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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03008031

Enrollment

Registered

2017-01-02

Start date

2017-01-31

Completion date

2020-04-30

Last updated

2022-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasm, Contrast-enhanced Spectral Mammography

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.

Interventions

PROCEDURECESM with a reduced dose of contrast agent

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026