To determine the minimum number of CESB-guided tissue samples needed to establish a final histopathological biopsy diagnosis for ROLs.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study aim will be to calculate the cumulative diagnostic yield per
specimen, enabling us to define a minimum number of biopsies required (or
tissue volume needed) to establish a reliable diagnosis using CESB.
Secondary outcome
Secondary study outcomes will be general parameters of the biopsy procedure
itself, such as patient characteristics, histopathological results, pain
experienced during the procedure, and complication rates (hematoma, infection).
Background summary
Contrast-enhanced mammography (CEM) is an emerging breast imaging modality that
is based on dual-energy mammography and the injection of iodinated contrast
agent. Studies have shown that the diagnostic accuracy of CEM is consistently
superior to full-field digital mammography (FFDM), even matching the accuracy
of breast MRI. A typical CEM study consists of a low-energy image (equal to a
FFDM image) and a recombined image (in which areas of contrast enhancement can
be appreciated). However, the situation can occur that lesions are visible only
on the recombined (contrast) images (in this protocol defined as *recombined-
only lesions* or ROLs). In these cases, we cannot fall back on conventional
stereotactic biopsy since there is no correlate on low-energy (mammographic)
images, nor is there a correlate on targeted ultrasound. In these cases, women
need to *contrast-enhanced stereotactic biopsy* (CESB) to achieve a final
tissue diagnosis.
However, experiences with CESB are still limited and one of the most urgent
questions that need to be answered is the amount of tissue sampling that is
required to reach a final diagnosis. With conventional stereotactic biopsy,
often for calcifications, the presence of calcifications can be confirmed with
specimen radiography. However, with ROLs there is no visual confirmation
possible to confirm the accurate positioning of the biopsy. Hence, we need to
study where the cut off will be in terms of tissue sampling volume needed
(i.e., number of biopsies) for a reliable diagnosis.
Study objective
To determine the minimum number of CESB-guided tissue samples needed to
establish a final histopathological biopsy diagnosis for ROLs.
Study design
Prospective, single center, observational cohort study.
Study burden and risks
The burden and risk for participating subjects is not increased in this study.
Participants recently underwent CEM, thereby proving that they have no relevant
renal insufficiencies to receive a second dose of contrast agent and proving
that they have no hypersensitivity reactions to the contrast agent itself. The
biopsy procedure itself is comparable with that of a standard stereotactic
biopsy (the only difference is the administration of contrast via an
intravenous catheter) and is associated with a very small risk of hematoma or
infections. However, participation in this study do not increase these risks.
Dr. H. van der Hoffplein 1
Geleen 6162BG
NL
Dr. H. van der Hoffplein 1
Geleen 6162BG
NL
Listed location countries
Age
Inclusion criteria
Included women are older than 18 years of age, with a recent finding on CEM
requiring CESB (a so-called 'recombined image only lesion' or ROL). Only women
able to provide written informed consent will be considered for this study.
Exclusion criteria
Excluded are all men (male sex), and women (female sex) who are
contra-indicated for CESB (for example, with impaired renal function or known
hypersensitivity reactions to iodinated contrast). Also excluded are pregnant
women.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL84611.096.23 |