NCT04084067

Brief Summary

This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and/or metastatic deposits is critical for achieving a cure. An optimal intra-operative tool to help visualize tumor and its margins would be of benefit. ICG real-time fluorescence imaging is a technique being used increasingly in adults for this purpose. We propose to use it during surgery for pediatric malignancies. All patients with tumors that require localization for resection or biopsy of the tumor and/or metastatic lesions will be eligible. Primary Objective To assess the feasibility of Indocyanine Green (ICG)-mediated near-infrared (NIR) imagery to identify neoplastic disease during the conduct of surgery to resect neoplastic lesions in children and adolescents. NIR imaging will be done at the start of surgery to assess NIR-positivity of the lesion(s) and at the end of surgery to assess completeness of resection. Separate assessments will be made for the following different histologic categories:

  1. 1.Osteosarcoma
  2. 2.Neuroblastoma
  3. 3.Metastatic pulmonary deposits - closed to accrual
  4. 4.To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated.
  5. 5.Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback.
  6. 6.Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging.
  7. 7.Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection.
  8. 8.Ewing Sarcoma
  9. 9.Rhabdomyosarcoma (RMS)
  10. 10.Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
  11. 11.Renal tumors
  12. 12.Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started Feb 2020

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Feb 2020Dec 2027

First Submitted

Initial submission to the registry

September 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

6.5 years

First QC Date

September 4, 2019

Last Update Submit

April 24, 2026

Conditions

Neoplastic DiseaseSolid Tumor

Keywords

Ewing SarcomaLiver tumorLymphomaMetastatic pulmonary depositsNeoplastic DiseaseNeuroblastomaNon-Rhabdomyosarcoma Soft Tissue SarcomaNodules of unknown etiologyOsteosarcomaSolid TumorRhabdomyosarcomaRenal tumorsRare tumors

Outcome Measures

Primary Outcomes (1)

  • Sensitivity rates of the ICG guided neoplastic disease identification

    Participants in each of the primary objective categories will be evaluated for this objective.

    up to 24 hours post-surgery

Other Outcomes (2)

  • Sensitivity rates of the ICG guided neoplastic disease identification

    up to 24 hours post-surgery

  • Sensitivity and specificity rates of the ICG guided residual (lymph node and tumor bed) neoplastic disease identification

    up to 24 hours post-surgery

Study Arms (1)

Indocyanine green (ICG)

EXPERIMENTAL

Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes prior to surgery.

Drug: Indocyanine Green

Interventions

Indocyanine GreenDRUG

IV

Also known as: IC-GREEN™, ICG
Indocyanine green (ICG)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.

You may not qualify if:

  • Subjects with a history of iodide allergies.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  • Patients with benign pathology.
  • Patients with brain tumors.
  • Pregnant female.
  • Patients with unilateral Wilms Tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

RECRUITING

Related Publications (1)

  • Abdelhafeez AH, Mothi SS, Pio L, Mori M, Santiago TC, McCarville MB, Kaste SC, Pappo AS, Talbot LJ, Murphy AJ, Davidoff AM. Feasibility of indocyanine green-guided localization of pulmonary nodules in children with solid tumors. Pediatr Blood Cancer. 2023 Oct;70(10):e30437. doi: 10.1002/pbc.30437. Epub 2023 May 17.

    PMID: 37194488DERIVED

Related Links

MeSH Terms

Conditions

NeoplasmsSarcoma, EwingCarcinoma, HepatocellularLymphomaNeuroblastomaSarcomaOsteosarcomaRhabdomyosarcomaCarcinoma, Renal Cell

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueMyosarcomaNeoplasms, Muscle TissueKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Lindsay Talbot, MD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay Talbot, MD

CONTACT

888-226-4343referralinfo@stjude.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2019

First Posted

September 10, 2019

Study Start

February 7, 2020

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be made available at the time of article publication.
Access Criteria
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

Locations

US(1)