Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06062992
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-09-25
Brief Title:
Contrast-Enhanced Stereotactic Biopsy
Sponsor:
Zuyderland Medisch Centrum
Organization:
Zuyderland Medisch Centrum
Study Overview
Official Title:
Assessing the Optimal Amount of Tissue Sampling in Contrast-Enhanced Stereotactic Biopsy CESB
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CESB
Brief 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 ie number of biopsies for a reliable 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 The investigators aim to study where the cut off will be in terms of tissue sampling volume needed ie number of biopsies for a reliable diagnosis
Detailed Description:
Rationale 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 ie number of biopsies for a reliable diagnosis
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 population Non-pregnant women 18 years able to provide written informed consent and with a ROL recently observed during a regular CEM examination
Intervention Included subject will undergo CESB consisting of an intravenous injection of iodinated contrast agent prior to image acquisition After administration a contrast-enhanced stereotactic localization will be performed of the ROL to determine the location and depth of the lesion within the breast After targeting 18 samples will be acquired using a 9 Gauge vacuum-assistend biopsy VAB collected in six separate and numbered cassettes to be able to determine the chronological order of the tissue sampling Each specimen will be histologically analyzed in this chronological order and findings will be compared with the final histopathological result after assessment of all 18 specimens
Main study parametersendpoints 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 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
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 ie number of biopsies for a reliable diagnosis
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 population Non-pregnant women 18 years able to provide written informed consent and with a ROL recently observed during a regular CEM examination
Intervention Included subject will undergo CESB consisting of an intravenous injection of iodinated contrast agent prior to image acquisition After administration a contrast-enhanced stereotactic localization will be performed of the ROL to determine the location and depth of the lesion within the breast After targeting 18 samples will be acquired using a 9 Gauge vacuum-assistend biopsy VAB collected in six separate and numbered cassettes to be able to determine the chronological order of the tissue sampling Each specimen will be histologically analyzed in this chronological order and findings will be compared with the final histopathological result after assessment of all 18 specimens
Main study parametersendpoints 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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None