Pediatric Solid TumorsT-LyMNCT07054944
Tumor-Lymph Node Mapping
An observational study of Pediatric Solid Tumors and Rhabdomyosarcoma, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility and safety of ICG-guided intraoperative lymphography for detecting sentinel lymph nodes (SLN) in pediatric patients with solid tumors who require retroperitoneal lymph node dissection/sampling. This trial is a single-site cross-sectional study. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Pediatric Solid Tumors, Rhabdomyosarcoma, Sarcoma
- What is being tested?
- ICG (Indocyanine Green)
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2026to 30 Jul 2028
- Phase
- Observational
- 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 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged 1 month to 17 years with diagnosed solid tumors who are receiving care at the University of Rochester Medical Center (URMC), Department of Surgery. Eligible participants are those scheduled to undergo lymph node sampling as part of standard clinical management. Participants will be identified through pediatric oncology, pediatric surgery, and tumor board evaluations.
Who may be able to join
- Any pediatric patient (under the age of 18 years) being treated at the University of Rochester Medical Center, Department of Surgery.
- Diagnosed with pediatric solid tumor
- Scheduled to undergo lymph node sampling as part of their clinical management.
Who cannot join
- Subjects with a history of iodide allergies.
- Inability or unwillingness of research participant or parent/legal guardian to give written informed consent.
- Currently pregnant.
- Infants under 650 grams.
- Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Abdelhafeez Abdelhafeez, MD contact
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
Abdelhafeez Abdelhafeez, Abdelhafeez_Abdelhafeez@URMC.Rochester.edu
About this study
Official title: FEASIBILITY AND SAFETY OF INDOCYANINE GREEN (ICG) GUIDED SENTINEL LYMPH NODE MAPPING FOR PEDIATRIC SOLID TUMORS - T-LyM (Tumor-Lymph Node Mapping)
The purpose of this study is to assess the feasibility and safety of ICG-guided intraoperative lymphography for detecting sentinel lymph nodes (SLN) in pediatric patients with solid tumors who require retroperitoneal lymph node dissection/sampling.
This trial is a single-site cross-sectional study. The injection of ICG directly into lymphatics draining the primary tumor will take place at the time of operation after the patient is under anesthesia.
- Conditions
- Pediatric Solid Tumors, Rhabdomyosarcoma, Sarcoma, Germ Cell Tumor
- Being tested
- ICG (Indocyanine Green)
- Keywords
- PEDIATRIC CANCER
- Medical subject headings
- Rhabdomyosarcoma, Sarcoma, Neoplasms, Germ Cell and Embryonal, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG (Indocyanine Green)Diagnostic test
Lymphatic mapping
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine Green (ICG) and KARL STORZ ICG Imaging System | Not described Receives: Diagnostic Test: ICG (Indocyanine Green) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence
Success is defined as the intraoperative identification of at least one fluorescent sentinel lymph node (SLN) after indocyanine green (ICG) injection using an Iridium system optimized for near-infrared detection. Visualization of the SLN indicates uptake of ICG within the lymphatic basin.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start13 Dec 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid TumorsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafeez Abdel, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054944
- Sponsor's protocol ID
- STUDY00010277
- Acronym
- T-LyM
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEASIBILITY AND SAFETY OF INDOCYANINE GREEN (ICG) GUIDED SENTINEL LYMPH NODE MAPPING FOR PEDIATRIC SOLID TUMORS - T-LyM (Tumor-Lymph Node Mapping)
- ClinicalTrials.gov ID
- NCT07054944
- Acronym / sponsor ID
- T-LyM / STUDY00010277
- Conditions
- Pediatric Solid Tumors, Rhabdomyosarcoma, Sarcoma, Germ Cell Tumor
- Keywords
- PEDIATRIC CANCER
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 13 Dec 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 8 Jul 2025 (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 purpose of this study is to assess the feasibility and safety of ICG-guided intraoperative lymphography for detecting sentinel lymph nodes (SLN) in pediatric patients with solid tumors who require retroperitoneal lymph node dissection/sampling.
This trial is a single-site cross-sectional study. The injection of ICG directly into lymphatics draining the primary tumor will take place at the time of operation after the patient is under anesthesia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine Green (ICG) and KARL STORZ ICG Imaging System | – | Diagnostic Test: ICG (Indocyanine Green) |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 1 month to 17 years with diagnosed solid tumors who are receiving care at the University of Rochester Medical Center (URMC), Department of Surgery. Eligible participants are those scheduled to undergo lymph node sampling as part of standard clinical management. Participants will be identified through pediatric oncology, pediatric surgery, and tumor board evaluations.
Key inclusion criteria (3 listed)
- Any pediatric patient (under the age of 18 years) being treated at the University of Rochester Medical Center, Department of Surgery.
- Diagnosed with pediatric solid tumor
- Scheduled to undergo lymph node sampling as part of their clinical management.
Key exclusion criteria (5 listed)
- Subjects with a history of iodide allergies.
- Inability or unwillingness of research participant or parent/legal guardian to give written informed consent.
- Currently pregnant.
- Infants under 650 grams.
- Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.
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 |
|---|---|---|
| ICG (Indocyanine Green)Lymphatic mapping | Diagnostic test | Indocyanine Green (ICG) and KARL STORZ ICG Imaging System |
Primary outcome
Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence
Time frame: Baseline
Success is defined as the intraoperative identification of at least one fluorescent sentinel lymph node (SLN) after indocyanine green (ICG) injection using an Iridium system optimized for near-infrared detection. Visualization of the SLN indicates uptake of ICG within the lymphatic basin.
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 26 Aug 2026.
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NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
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Natural History and Biospecimen Acquisition for Children and Adults With Rare Solid Tumors
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Not yet recruitingPhase 2
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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.
Abdelhafeez Abdelhafeez, MD contact
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 Pediatric Solid Tumors and Rhabdomyosarcoma, run by University of Rochester at 1 site in United States.
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 5 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: opening soon, as of the sponsor's last update on 26 Aug 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 United States. 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 Abdelhafeez Abdelhafeez, MD (Abdelhafeez_Abdelhafeez@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence (time frame: Baseline). 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 26 Aug 2026.