Breast CancerCESBNCT06062992
Contrast-Enhanced Stereotactic Biopsy
An observational study of Breast Cancer and Breast Neoplasms, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- What is being tested?
- Contrast Enhanced Stereotactic Biopsy
- How many people
- 77 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Oct 2023to 16 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All women recently underwent CEM in our hospital, showing a ROL. Common indications to perform a CEM examination in our hospital are: recalls from breast cancer screening, as problem-solving tool after inconclusive FFDM and/or ultrasound, breast MRI alternative, preoperative staging of breast cancer and baseline examination for women treated with neoadjuvant systemic therapy (where CEM will be used as response monitoring tool).
Who may be able to join
- Women >18 years of age;
- Recent detection of a ROL on CEM;
- Able to provide written informed consent.
Who cannot join
- All men (male sex);
- Women (female sex) who are contra indicated for CESB (for example: impaired renal function, known hypersensitivity to iodinated contrast);
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Optimal Amount of Tissue Sampling in Contrast-Enhanced Stereotactic Biopsy (CESB)
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.
Read the 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 (i.e., 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 parameters/endpoints: 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).
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- Being tested
- Contrast Enhanced Stereotactic Biopsy
- Keywords
- Breast cancer, Mammography, CEM, Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced Stereotactic BiopsyDiagnostic test
Stereotactic breast biopsy using CEM as targeting modality
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Contrast Enhanced Stereotactic Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of tissue needed for CESB
The investigators calculate the diagnostic yield per biopsy sample to establish to minimum amount of tissue samples needed for CESB
Measured: 2 years
Secondary outcomes (3)
Complication rate
The investigators will establish the complication rate of CESB (for example: hematoma, technical failures, infection)
Measured: 2 years
Diagnostic results
The investigators will establish the various diagnostic outcomes (pathology results) of the biopsies performed using CESB
Measured: 2 years
Patient comfort
The investigators will establish the patient (dis)comfort of CESB by scoring the pain associated with this intervention on a 0-10 scale (0 no pain, 10 worst pain ever)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start13 Oct 2023
- Primary completion15 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Hologic, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062992
- Sponsor's protocol ID
- ZuyderlandMC_CESB
- Acronym
- CESB
- Status last verified
- Feb 2026
- First submitted
- 25 Sep 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Anonymized data can be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Optimal Amount of Tissue Sampling in Contrast-Enhanced Stereotactic Biopsy (CESB)
- ClinicalTrials.gov ID
- NCT06062992
- Acronym / sponsor ID
- CESB / ZuyderlandMC_CESB
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Cancer Female
- Keywords
- Breast cancer, Mammography, CEM, Biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Collaborators
- Hologic, Inc.
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (i.e., 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 parameters/endpoints: 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with 'recombined imaging only lesions' or ROLs | – | Diagnostic Test: Contrast Enhanced Stereotactic BiopsyWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All women recently underwent CEM in our hospital, showing a ROL. Common indications to perform a CEM examination in our hospital are: recalls from breast cancer screening, as problem-solving tool after inconclusive FFDM and/or ultrasound, breast MRI alternative, preoperative staging of breast cancer and baseline examination for women treated with neoadjuvant systemic therapy (where CEM will be used as response monitoring tool).
Key inclusion criteria (3 listed)
- Women >18 years of age;
- Recent detection of a ROL on CEM;
- Able to provide written informed consent.
Key exclusion criteria (3 listed)
- All men (male sex);
- Women (female sex) who are contra indicated for CESB (for example: impaired renal function, known hypersensitivity to iodinated contrast);
- Pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Enhanced Stereotactic BiopsyStereotactic breast biopsy using CEM as targeting modality | Diagnostic test | Patients with 'recombined imaging only lesions' or ROLs |
Primary outcome
Amount of tissue needed for CESB
Time frame: 2 years
The investigators calculate the diagnostic yield per biopsy sample to establish to minimum amount of tissue samples needed for CESB
3 secondary outcomes
Complication rate
Time frame: 2 years
Diagnostic results
Time frame: 2 years
Patient comfort
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Yes. Anonymized data can be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Neoplasms, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of tissue needed for CESB (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.