ClinicalTrials.gg
Not yet recruitingNCT07054944T-LyMUpdated Aug 26, 2026

Tumor-Lymph Node Mapping

An observational study in Pediatric Solid Tumors, Rhabdomyosarcoma and Sarcoma, sponsored by University of Rochester. Not yet recruiting at 1 site in United States. Open to participants aged 1 Month to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by University of Rochester · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10
Ages
1 Month to 17 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 179 studies in Rhabdomyosarcoma with a site in United States — 30 open to participants now, 56 under way, 3 of them phase 3. Rhabdomyosarcoma · United States.

Planned enrollment
12th of 14
10 · median 125
Started
2026
with 7 others
Observational
14 of 179
4 open now
Primary completion
2028-07
later than 41 of 55 live
Registered
172nd of 179
by date

Among the 179 studies in Rhabdomyosarcoma with a site in United States, this one is the 12th largest by planned enrollment of the 14 observational ones that give a count, is one of 8 that started in 2026, is one of 14 observational ones, reaches primary completion later than 41 of the 55 other live ones, and was the 172nd registered.

Rhabdomyosarcoma

238 studies on the registry are indexed under Rhabdomyosarcoma; 49 are open to participants now.

Browse Rhabdomyosarcoma studies →

Open to participants now

30 of the 179 studies in Rhabdomyosarcoma with a site in United States are open now. Recruiting first, the newest first:

25 more — sign in →

All 30 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 39 Rhabdomyosarcoma studies recruiting now, 8 (21%) set no upper age limit and 31 (79%) stop at 75 or younger; 35 take children under 18; 0 take healthy volunteers.

This study: 1 Month to 17 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 179 studies in Rhabdomyosarcoma with a site in United States, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Pediatric Solid Tumors
  • Rhabdomyosarcoma
  • Sarcoma
  • Germ Cell Tumor

Keywords

  • PEDIATRIC CANCER
04

Who can participate

Ages eligible
1 Month to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Subjects with a history of iodide allergies.
  • Inability or unwillingness of research participant or parent/legal guardian to give written .
  • Currently pregnant.
  • Infants under 650 grams.
  • Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • Indocyanine Green (ICG) and KARL STORZ ICG Imaging System

    Diagnostic Test: ICG (Indocyanine Green)

Interventions

  • Diagnostic testICG (Indocyanine Green)

    Lymphatic mapping

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Other outcomes

  1. Accuracy of SLN Biopsy as Measured by Concordance Between SLN Pathology and Nodal Basin Pathology

    Accuracy is assessed by comparing the pathology results of the SLN and the retroperitoneal lymph node basin dissection. True positives and true negatives are defined as SLN and nodal basin showing matching tumor status (both positive or both negative). Discordant finding is defined as tumor basin positive for tumor while SLN is negative for tumor. Discordant findings are considered false negatives. A tumor positive SLN in a tumor negative nodal basin is not considered discordant or false positive because sentinel may be the first and only tumor involved lymph node within the nodal basin.

    Time frame: During surgery (Day 0), based on intraoperative and postoperative pathology reports finalized within 7 days

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Jul 2028, 19 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2025
First posted
Jul 8, 2025
StartEst.
Dec 13, 2026
Primary completionEst.
Jul 30, 2028
CompletionEst.
Jul 30, 2028
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07054944
Responsible party
Hafeez Abdel (Associate Professor - Department of Surgery, Pediatric Surgery (SMD), University of Rochester) — Principal investigator
First posted
Jul 8, 2025
Start date
Dec 13, 2026 (estimated)
Primary completion
Jul 30, 2028 (estimated)
Completion
Jul 30, 2028 (estimated)
Last update
Aug 26, 2026

Study contacts

Abdelhafeez Abdelhafeez, MD
Contact
Abdelhafeez_Abdelhafeez@URMC.Rochester.edu

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion