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

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT03008031

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm Contrast-enhanced Spectral Mammography	Procedure: CESM with a reduced dose of contrast agent	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: arm A (40%) Patients randomized in arm A will receive a second CESM exam with 40% of the initial dose of the contrast agent.	Procedure: CESM with a reduced dose of contrast agent
Experimental: arm B (60%) Patients randomized in arm A will receive a second CESM exam with 60% of the initial dose of the contrast agent.	Procedure: CESM with a reduced dose of contrast agent
Experimental: arm C (80%) Patients randomized in arm A will receive a second CESM exam with 80% of the initial dose of the contrast agent.	Procedure: CESM with a reduced dose of contrast agent

Arm

Intervention/Treatment

Experimental: arm A (40%)

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

Procedure: CESM with a reduced dose of contrast agent

Experimental: arm B (60%)

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

Procedure: CESM with a reduced dose of contrast agent

Experimental: arm C (80%)

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

Procedure: CESM with a reduced dose of contrast agent

Outcome Measures

Primary Outcome Measures

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

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center	Maastricht		Netherlands

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator: Marc BI Lobbes, MD, PhD, Maastricht University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT03008031

Other Study ID Numbers:

162048

First Posted:

Jan 2, 2017

Last Update Posted:

Apr 19, 2017

Last Verified:

Apr 1, 2017

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Apr 19, 2017