Robot ultrasound vs handheld: can a machine spot cancer in reconstructed breasts?
NCT ID NCT05408260
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two types of ultrasound for monitoring women who have had breast reconstruction after cancer. One is the standard handheld ultrasound, the other is an automated machine that scans the breast. The goal is to see if the automated version can detect leftover breast tissue just as well. Only 12 women took part, so this is a very early look at whether the automated method might be useful.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ultrasound imaging (automated and handheld)
- What this could lead to
- If successful, this could show that automated breast ultrasound is a reliable, convenient option for monitoring women after breast reconstruction.
- What could go wrong
- This is a very small, early feasibility study with only 12 participants. It does not test cancer detection directly, only imaging artifacts, so results may not change practice.
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.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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12 people
The number who actually took part.
- Started
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Nov 2022
- Finished
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Feb 2025
- Lead sponsor
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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.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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: * Female * \>= 18 years of age at time of consent * Free of focal breast symptoms and with no suspicious breast physical exam findings * Previous unilateral NSM or SSM with implant (silicone, saline) or flap reconstruction performed at Thomas Jefferson University Hospital * Must be able to understand and provide signed and dated informed consent form. If a patient understands the informed consent but is unable to sign, a legally authorized representative (LAR) may sign * Willing to comply with all study procedures and be available for the duration of the study * Willing to honor any bills that may be incurred if the insurance company does not pay for the billed bilateral hand held ultrasound Exclusion Criteria: * History of breast cancer recurrence * Current focal breast symptoms since NSM or SSM with reconstruction * NSM or SSM with reconstruction was performed years prior to study enrollment * Bilateral NSM or SSM with reconstruction * Females who are pregnant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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