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How many samples are enough? study aims to perfect breast biopsy technique

NCT ID NCT06062992

Diagnosis Sponsor: Zuyderland Medisch Centrum Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how many tissue samples are needed when doing a special type of breast biopsy called contrast-enhanced stereotactic biopsy (CESB). The biopsy is used for breast lesions that only show up on contrast-enhanced mammography. Researchers studied 77 women to find the minimum number of samples needed for a reliable diagnosis, while also tracking complications and patient comfort.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Contrast Enhanced Stereotactic Biopsy (diagnostic test)
What this could lead to
If successful, this could establish a standard for how many biopsy samples are needed, reducing unnecessary procedures while ensuring accurate diagnosis.
What could go wrong
This is a small, completed study (77 participants) focused on procedure optimization, not a new treatment. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

77 people

The number who actually took part.

Started

Oct 2023

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Women \>18 years of age; * Recent detection of a ROL on CEM; * Able to provide written informed consent. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm female breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Breast cancer female Breast neoplasms

Contacts and locations

Locations

  • Zuyderland Medical Center

    Sittard, Limburg, 6162BG, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.