CESM is a novel mammography technique that has been shown to be superior to conventional full-field digital mammography (FFDM). In a CESM exam, iodine based contrast agents, similar to those used in for example computed tomography (CT) exams, are…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
All exams will be reviewed by two expert CESM radiologists, blinded for
contrast dose used, final tumor pathology and extent, and each other*s results.
The primary study parameter will be assessed for both the clinical and reduced
CESM exam and will consist of maximum tumor diameter. Final tumor pathology
results as assessed on the surgical specimen will serve as the gold standard.
Secondary outcome
Enhancement measurements for breast cancer detected with the clinical CESM exam
(reference) compared to the (experimental) CESM exams with varying (lower) dose
concentrations.
Background 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.
Study objective
CESM is a novel mammography technique that has been shown to be superior to
conventional full-field digital mammography (FFDM). In a CESM exam, iodine
based contrast agents, similar to those used in for example computed tomography
(CT) exams, are used. However, there is currently insufficient knowledge on the
optimal dose of iodine based contrast agents used in CESM.
Study design
Cross-sectional diagnostic study.
Intervention
The diagnosis of breast cancers was made by using a well-validated protocol of
our institute using an intravenous administration of iopromide (Ultravist 300,
1.5 mL/kg bodyweight). 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.
Study burden and risks
A CESM exam has several disadvantages or potential complications. However, they
are very limited and consist of an intravenous catheter placement and contrast
administration, risk of analphylactic shock and renal failure due to the
contrast administration and an increased radiation dose due to a second (CESM)
exam. The risks of these potential complications are limited: intravenous
catheter placement and contrast administration are extensively used in clinical
practice and rare result in relevant complications, especially since only
patients with adequate renal clearance are included; the risk of an
anaphylactic adverse event is neglible since all patients have already received
a clinical CESM exam prior before the second exam.
P debyelaan 25
Maastricht 6229 HX
NL
P debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
1. Female patient with histopathogically confirmed invasive breast cancer who recently underwent a clinical CESM exam without complications;
2. Treated with primary surgery;
3. Willing and able to undergo all study procedures;
4. Has personally provided written informed consent.
5. Age * 18
Exclusion criteria
1. Pregnancy
2. Allergy for any of the ingredients of (Ultravist) contrast agent
3. Being unable to give informed consent in person
4. History of coronary arterial disease or unstable angina
5. Acute or chronic severe renal insufficiency (glomerular filtration rate < 45 mL/min/1.732)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03008031 |
| CCMO | NL59189.068.16 |