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New imaging tool could help surgeons detect hidden cancer cells during surgery

NCT ID NCT07702721

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests a new imaging technique that could help surgeons see if cancer has spread to lymph nodes during surgery for gynecologic cancers like ovarian, endometrial, cervical, and vulvar cancer. The method uses a special microscope to examine lymph node tissue right after it is removed, without needing to stain or process it first. Researchers will compare the results with standard lab tests to see how accurate the new approach is. If it works well, it could help doctors make faster decisions during surgery.

What this could mean

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

Active substance
Full-Field Optical Coherence Tomography (FF-OCT) combined with Dynamic Cell Imaging (DCI) using the Van Gogh System
What this could lead to
If successful, this imaging technique could allow surgeons to detect cancer in lymph nodes during surgery, potentially reducing the need for additional procedures.
What could go wrong
This is an early-stage observational study, so the technology may not prove accurate enough for routine use. It also requires specialized equipment and training.

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

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

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

women undergoing surgery for gynecological cancers

Ages

18 to 99 years

Sex

Female participants only

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 undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical and vulvar cancer) * Need for sentinel lymph nodal excision (staging) * Need for lymph nodal dissection (staging/ cytoreductive reasons) * 18-99 years old * Absence of contemporary lymphatic diseases * Absence of previous oncological disease in the last 5 years Exclusion Criteria: Presence of lymphoproliferative or granulomatous diseases affecting lymph nodes * Active systemic infection or inflammatory conditions influencing lymph node architecture * Poor-quality lymph node specimens (necrotic, damaged, or with significant optical artifacts) * Inadequate histopathological reference standard or inability to correlate imaging with histology * Failure of sentinel lymph node mapping or non-standardized surgical procedures * Prolonged ischemia time or improper specimen handling prior to imaging (\>30 mins)

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Conditions

The condition(s) this trial relates to.

cervical cancer endometrial cancer endometrium neoplasm female reproductive organ cancer ovarian cancer Uterine Cervical Neoplasms vulva cancer

As listed by the trial registrant

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

Cervical cancer Endometrial cancer Gynecologic cancer Ovary cancer Vulvar cancer

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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