Assessing the Optimal Amount of Tissue Sampling in Contrast-Enhanced Stereotactic Biopsy (CESB)

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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. 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, radiologists need to perform 'contrast-enhanced stereotactic biopsy' (CESB), in which CEM is used as a targeting modality. 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. The investigators aim to study where the cut off will be in terms of tissue sampling volume needed (i.e., number of biopsies) for a reliable diagnosis.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• Women \>18 years of age;

• Recent detection of a ROL on CEM;

• Able to provide written informed consent.

Locations
Other Locations
Netherlands
Zuyderland Medical Center
RECRUITING
Sittard
Contact Information
Primary
Marc Lobbes, MD, PhD
m.lobbes@zuyderland.nl
+31884597777
Time Frame
Start Date: 2023-10-13
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 150
Treatments
Patients with 'recombined imaging only lesions' or ROLs
Women that recently underwent CEM, which showed a suspicious breast lesion only on the recombined (enhancement) images: a 'recombined image only lesions' or ROL. These women are indicated to undergo CESB.
Related Therapeutic Areas
Sponsors
Collaborators: Hologic, Inc.
Leads: Zuyderland Medisch Centrum

This content was sourced from clinicaltrials.gov