Indocyanine Green (ICG) Guided Tumor Resection

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. Osteosarcoma
2. Ewing Sarcoma
3. Rhabdomyosarcoma (RMS)
4. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
5. Neuroblastoma
6. Renal tumors (Only bilateral Wilms Tumor patients will be included.)
7. Metastatic pulmonary deposits
8. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

Exploratory Objectives

1. To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated.
2. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback.
3. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging.
4. Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Neoplastic Disease
• Intervention / Treatment: Drug: Indocyanine Green

Detailed Description

This trial is a single center open-label study. Patients with a solid tumor or lymphoma who require resection either for therapeutic or diagnostic intent will be included.

Indocyanine Green (ICG) is an FDA-approved drug. Prior to surgery, patients will receive a single dose of ICG intravenously.

During surgery, after the surgeon identifies the mass through visual (seen with the naked eye) and or tactile methods (palpated), the patient will have his/her tumor field imaged by Iridium system optimized for detection of ICG (Visionsense Corp, Philadelphia, PA). The entire procedure will be photo- documented and recorded.

The Visionsense system records images in real time, calculates percentages, and captures the data. At least three different areas of the tumor will be measured. If the tumor cannot be identified by visual inspection or palpation, NIR-imaging will be used in an attempt to locate the lesion. The surrounding area will be inspected and measured to screen for additional sites of metastatic disease. After tumor resection, residual fluorescence in the surgical resection bed will be measured.

Direct subject participation in the trial will last for the period of time from injection of the ICG the day before surgery and until 24 hours post-surgery.

• Study Type: Interventional
• Enrollment (Estimated): 312
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Abdelhafeez Abdelhafeez, MD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • Recruiting
      • St. Jude Children's Research Hospital
      • Contact: Abdelhafeez Abdelhafeez, MD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org
      • Principal Investigator: Abdelhafeez Abdelhafeez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Subjects with a history of iodide allergies, including positive allergic reaction to the screening iodine test.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indocyanine green (ICG); Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes prior to surgery.	Drug: Indocyanine Green; IV; Other Names: ICG; IC-GREEN™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity rates of the ICG guided neoplastic disease identification	The 312 patients (39 patients in each of the 8 categories) will be evaluated for this objective.	up to 24 hours post-surgery

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Investigators: Principal Investigator: Abdelhafeez Abdelhafeez, MD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• St. Jude Children's Research Hospital
• ClinicalTrials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 9, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Lymphoma; Solid Tumor; Ewing Sarcoma; Rhabdomyosarcoma; Osteosarcoma; Neuroblastoma; Liver tumor; Metastatic pulmonary deposits; Neoplastic Disease; Non-Rhabdomyosarcoma Soft Tissue Sarcoma; Nodules of unknown etiology; Renal tumors; Rare tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ICGLOW; NCI-2019-06146 (Registry Identifier: NCI Clinical Trial Registration Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be made available at the time of article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No