Clinical trial · Interventional
Reduced Contrast Administration in Contrast-enhanced Spectral Mammography (CESM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Contrast-enhanced Spectral Mammography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CESM with a reduced dose of contrast agent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- arm A (40%)
- description
- Patients randomized in arm A will receive a second CESM exam with 40% of the initial dose of the contrast agent.
- interventionNames
- Procedure: CESM with a reduced dose of contrast agent
- type
- EXPERIMENTAL
- label
- arm B (60%)
- description
- Patients randomized in arm A will receive a second CESM exam with 60% of the initial dose of the contrast agent.
- interventionNames
- Procedure: CESM with a reduced dose of contrast agent
- type
- EXPERIMENTAL
- label
- arm C (80%)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available