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

NCT03008031 | Terminated DMC

• 1 other identifier: 162048
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (3)

arm A (40%)

EXPERIMENTAL

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

arm B (60%)

EXPERIMENTAL

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

arm C (80%)

EXPERIMENTAL

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

Interventions

CESM with a reduced dose of contrast agent PROCEDURE

arm A (40%); arm B (60%); arm C (80%)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marc BI Lobbes, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Thiemo JA van Nijnatten, MD, PhD

  Maastricht University Medical Center

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: January 2, 2017
• Study Start: January 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

NL (1)