Indocyanine Green (ICG) Guided Tumor Resection

NCT ID: NCT04084067

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-07
• Study Completion Date: 2027-12-31

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. Osteosarcoma

2. Neuroblastoma

3. Metastatic pulmonary deposits - closed to accrual

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.

Separate assessments will be made for the following different histologic categories based on their actual enrollment; this includes but is not limited to analyzing multiple arms together:

1. Ewing Sarcoma

2. Rhabdomyosarcoma (RMS)

3. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

4. Renal tumors

5. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

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 (EleVision™ IR Platform). The entire procedure will be photo- documented and recorded.

The EleVision™ 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.

Conditions

Neoplastic Disease; Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Indocyanine green (ICG)

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

Group Type: EXPERIMENTAL

Indocyanine Green

Intervention Type: DRUG

IV

Interventions

Indocyanine Green

IV

Intervention Type: DRUG

Other Intervention Names

IC-GREEN™; ICG

Eligibility Criteria

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.
• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay Talbot, MD

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsay Talbot, MD

Role: CONTACT

referralinfo@stjude.org

866-278-5833

Facility Contacts

Lindsay Talbot, MD

Role: primary

referralinfo@stjude.org

866-278-5833

References

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.

Reference Type: DERIVED

PMID: 37194488 (View on PubMed)

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

ClinicalTrials Open at St. Jude

Other Identifiers

NCI-2019-06146

Identifier Type: REGISTRY

Identifier Source: secondary_id

ICGLOW

Identifier Type: -

Identifier Source: org_study_id