NCT04084067 Indocyanine Green (ICG) Guided Tumor Resection
| NCT ID | NCT04084067 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Neoplastic Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2020-02-07 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 230 participants in total. It began in 2020-02-07 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Lindsay Talbot, MD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT04084067 clinical trial?
This trial is open to participants of all sexes, studying Neoplastic Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04084067 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04084067 currently recruiting?
Yes, NCT04084067 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT04084067 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT04084067 clinical trial?
NCT04084067 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Lindsay Talbot, MD at St. Jude Children's Research Hospital. The trial plans to enroll 230 participants.