Lymph Node MetastasisR-LYNUSNCT06621823
Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies
A study testing image-guided surgery technique in people with Lymph Node Metastasis and Gynecologic Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The assessment of lymph node status is of crucial importance in gynaecological malignancies. Indeed, the prognosis and adjuvant treatment regimens are strongly influenced by the presence of nodal involvement. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Lymph Node Metastasis, Gynecologic Cancer
- What is being tested?
- image-guided surgery technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteItaly
- Study dates
- 25 Jul 2024to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women undergoing robotic surgery for gynecological malignancies (ovarian, endometrial, cervical cencers)
- Need for nodal excision (staging or cytoreductive reasons)
- 18-99 years old
- Absence of contemporary lymphatic diseases
- Absence of previous oncological disease in the last 5 years
- Willingness to participate in the study and to provide informed consent
Who cannot join
- - Previous radiotherapy treatments in the area of analysed lymph nodes
- Previous chemotherapy treatments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
ANTONIA CARLA TESTA, Professor, antoniacarla.testa@policlinicogemelli.it
Elena Teodorico, Dr, elena.teodorico@policlinicogemelli.it
About this study
The assessment of lymph node status is of crucial importance in gynaecological malignancies.
Indeed, the prognosis and adjuvant treatment regimens are strongly influenced by the presence of nodal involvement. Systematic extensive lymphadenectomies are often performed for staging, diagnosis of skip metastases and to define the radiation field when radiotherapy treatments are required. Nevertheless, these can lead to significant short-term and long-term lymphatic complications, which are difficult to justify if the lymph nodes are free from metastasis. To avoid unnecessary comprehensive procedures in early-stage cancers, evaluation of the sentinel lymph node has acquired a valuable role even if limitations are still present (rate of frozen section false negative, "empty packets" and mapping failure). The introduction of an intra-operative non-invasive imaging technique capable of describing the presence and characteristics of lymph nodes could help in (1) eliminating the risk of empty packet, (2) orienting the intraoperative decision while avoiding the drawbacks of frozen section (time and resources, partial destruction of the tissue material), (3) orientate the pathological section if frozen section is used. To date, technological advancements have paved the way for enhanced intra-operative assessment of cancerous organs and lesions. Over the past decade, the evolution of robotic surgery combined with advancements in image-guided surgery techniques has led to the introduction of ultrasound probes designed specifically for intraoperative ultrasound during robotic surgery (RIOUS). Apart from the conventional rigid laparoscopic probes, which can be inserted through an accessory trocar, there are robotic probes tailored to fit device arms, and drop-in flexible probes that are becoming increasingly relevant in the scientific panorama. Notably, the latter drop-in probes feature a rigid segment designed for compatibility with robotic graspers, leveraging the dexterity and rotational manoeuvrability inherent to robotic surgery. Such probes, already proven effective in evaluating liver and kidney lesions as well as tumour margins, hold promise for intraoperative lymph node assessments due to the possibility of reaching difficult anatomical spaces thanks to the robotic-assisted movements
Read the detailed description
Women undergoing radical surgery for gynecological cancers who meet the inclusion criteria in absence of exclusion criteria will be considered candidate for the study. Intraoperative robotic ultrasound will be performed on in vivo lymph nodal samples. Lymph nodes morphology and imaging characteristics will be evaluated. The gold standard will be definitive pathology.
- Conditions
- Lymph Node Metastasis, Gynecologic Cancer
- Being tested
- image-guided surgery technique
- Medical subject headings
- Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
image-guided surgery techniqueProcedure or surgery
The identification of an image-guided surgery technique capable of intraoperatively detecting the presence of lymph node metastases would overcome the disadvantages and complications of extensive staging lymphadenectomies.
| Study group | Role | What they receive |
|---|---|---|
| surgical lymph nodes | Other | Patients referred to the Gynecology Oncology Unit in Fondazione Policlinico A. Gemelli IRCCS, Italy, Rome with a diagnosis of gynecological malignancy requiring surgical lymph nodes harvest will be evaluated for the enrolment. Receives: Procedure: image-guided surgery technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of RIUS in detecting lymph node metastases (macro-, micro-metastases and isolated tumor cells)
The aim of this prospective trial is to evaluate the sensitivity of Real-time Intraoperative Ultrasound (RIUS) in detecting lymph node metastases, including macrometastases, micrometastases, and isolated tumor cells (ITCs), using fresh, unstained in vivo lymph node samples. Ultrasound images will be assessed according to the VITA (Vulva International Tumor Analysis) group consensus on morphological parameters. Final histopathological examination will serve as the gold standard for comparison.
Measured: 2 year
Secondary outcomes (1)
drop-in robotic ultrasound probe
The secondary endpoint is to assess the lowest size detectable with the adopted drop-in robotic ultrasound probe
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 posted1 Oct 2024
- Study start25 Jul 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymph Node MetastasisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia Carla Testa, Professor, Principal investigator, Fondazione Policlinico Universitario A. Gemelli, IRCCS, RomeFrancesco Fanfani, Professor, Study chair, Fondazione Policlinico Universitario A. Gemelli, IRCCS, RomeMatteo Pavone, MD, Study chair, Fondazione Policlinico Universitario A. Gemelli, IRCCS, RomeElena Teodorico, MD, Study chair, Fondazione Policlinico Universitario A. Gemelli, IRCCS, RomeDenis Querleu, Professor, Study chair, Fondazione Policlinico Universitario A. Gemelli, IRCCS, RomeGiovanni Scambia, Professor, Study director, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621823
- Sponsor's protocol ID
- 6534
- Acronym
- R-LYNUS
- Status last verified
- Jun 2025
- First submitted
- 20 May 2024
- Last updated
- 15 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pavone M, Teodorico E, Bizzarri N, Innocenzi C, Rosati A, Zorzi M, Cantarini C, Ciancia M, Moro F, Gallotta V, Marescaux J, Lecointre L, Fagotti A, Scambia G, Fanfani F, Testa A, Querleu D. Image-Guided Robotic Surgery for Sentinel Lymph Node Status Assessment in Uterine Cancers Using Ultrasound Drop-in Probe: Surgical Technique in 10 Steps. Ann Surg Oncol. 2025 May;32(5):3465-3466. doi: 10.1245/s10434-025-16912-x. Epub 2025 Feb 1.
PubMed 39893338
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT06621823
- Acronym / sponsor ID
- R-LYNUS / 6534
- Conditions
- Lymph Node Metastasis, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 25 Jul 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 1 Oct 2024 (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.
The assessment of lymph node status is of crucial importance in gynaecological malignancies.
Indeed, the prognosis and adjuvant treatment regimens are strongly influenced by the presence of nodal involvement. Systematic extensive lymphadenectomies are often performed for staging, diagnosis of skip metastases and to define the radiation field when radiotherapy treatments are required. Nevertheless, these can lead to significant short-term and long-term lymphatic complications, which are difficult to justify if the lymph nodes are free from metastasis. To avoid unnecessary comprehensive procedures in early-stage cancers, evaluation of the sentinel lymph node has acquired a valuable role even if limitations are still present (rate of frozen section false negative, "empty packets" and mapping failure). The introduction of an intra-operative non-invasive imaging technique capable of describing the presence and characteristics of lymph nodes could help in (1) eliminating the risk of empty packet, (2) orienting the intraoperative decision while avoiding the drawbacks of frozen section (time and resources, partial destruction of the tissue material), (3) orientate the pathological section if frozen section is used. To date, technological advancements have paved the way for enhanced intra-operative assessment of cancerous organs and lesions. Over the past decade, the evolution of robotic surgery combined with advancements in image-guided surgery techniques has led to the introduction of ultrasound probes designed specifically for intraoperative ultrasound during robotic surgery (RIOUS). Apart from the conventional rigid laparoscopic probes, which can be inserted through an accessory trocar, there are robotic probes tailored to fit device arms, and drop-in flexible probes that are becoming increasingly relevant in the scientific panorama. Notably, the latter drop-in probes feature a rigid segment designed for compatibility with robotic graspers, leveraging the dexterity and rotational manoeuvrability inherent to robotic surgery. Such probes, already proven effective in evaluating liver and kidney lesions as well as tumour margins, hold promise for intraoperative lymph node assessments due to the possibility of reaching difficult anatomical spaces thanks to the robotic-assisted movements
Detailed description
Women undergoing radical surgery for gynecological cancers who meet the inclusion criteria in absence of exclusion criteria will be considered candidate for the study. Intraoperative robotic ultrasound will be performed on in vivo lymph nodal samples. Lymph nodes morphology and imaging characteristics will be evaluated. The gold standard will be definitive pathology.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical lymph nodes | Other | Procedure: image-guided surgery techniquePatients referred to the Gynecology Oncology Unit in Fondazione Policlinico A. Gemelli IRCCS, Italy, Rome with a diagnosis of gynecological malignancy requiring surgical lymph nodes harvest will be evaluated for the enrolment. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women undergoing robotic surgery for gynecological malignancies (ovarian, endometrial, cervical cencers)
- Need for nodal excision (staging or cytoreductive reasons)
- 18-99 years old
- Absence of contemporary lymphatic diseases
- Absence of previous oncological disease in the last 5 years
Key exclusion criteria (2 listed)
- - Previous radiotherapy treatments in the area of analysed lymph nodes
- Previous chemotherapy treatments
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 |
|---|---|---|
| image-guided surgery techniqueThe identification of an image-guided surgery technique capable of intraoperatively detecting the presence of lymph node metastases would overcome the disadvantages and complications of extensive staging lymphadenectomies. | Procedure or surgery | surgical lymph nodes |
Primary outcome
Sensitivity of RIUS in detecting lymph node metastases (macro-, micro-metastases and isolated tumor cells)
Time frame: 2 year
The aim of this prospective trial is to evaluate the sensitivity of Real-time Intraoperative Ultrasound (RIUS) in detecting lymph node metastases, including macrometastases, micrometastases, and isolated tumor cells (ITCs), using fresh, unstained in vivo lymph node samples. Ultrasound images will be assessed according to the VITA (Vulva International Tumor Analysis) group consensus on morphological parameters. Final histopathological examination will serve as the gold standard for comparison.
1 secondary outcome
drop-in robotic ultrasound probe
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Derived from this study: PubMed 39893338Pavone M, Teodorico E, Bizzarri N, Innocenzi C, Rosati A, Zorzi M, Cantarini C, Ciancia M, Moro F, Gallotta V, Marescaux J, Lecointre L, Fagotti A, Scambia G, Fanfani F, Testa A, Querleu D. Image-Guided Robotic Surgery for Sentinel Lymph Node Status Assessment in Uterine Cancers Using Ultrasound Drop-in Probe: Surgical Technique in 10 Steps. Ann Surg Oncol. 2025 May;32(5):3465-3466. doi: 10.1245/s10434-025-16912-x. Epub 2025 Feb 1.
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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.
Antonia Carla Testa, Professor principal investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
Francesco Fanfani, Professor study chair
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
Matteo Pavone, MD study chair
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing image-guided surgery technique in people with Lymph Node Metastasis and Gynecologic Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 6 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Jun 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonia Carla Testa (0630156399, antoniacarla.testa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of RIUS in detecting lymph node metastases (macro-, micro-metastases and isolated tumor cells) (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06621823, which also lists 1 linked publication.
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 15 Jun 2025.