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Indocyanine Green (ICG) Guided Tumor Resection

StatusCompleted
PhasePhase 1
Started2020-02-07
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
Study Status, Study Design, Contacts/Locations, Document Section v20
Trial completed
Study completion confirmed: August 2026 (last estimated December 2027)
Primary completion dateestimated 2026-08→confirmed 2026-07-28
Completion dateestimated 2027-12-31→confirmed 2026-08-26
Enrollment targetestimated 230→confirmed 215
Study sitesdetails revised at 1 of 1 site
2026-04-24
Study Status, Contacts/Locations v19
Study sitescontacts updated at 1 of 1 site
2025-11-03
Study Status v18
Primary completion date2025-12-31→2026-08
2025-05-14
Study Status, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v17
Completion date2025-12-31→2027-12-31
Enrollment target312→230
Eligibility criteria-67 characters
[...] lusion Criteria: Subjects with a history of iodide allergies, including positive allergic reaction to the screening iodine test. Inability or unwillingness of research participant or lega [...]
Primary endpoints1 entry, revised
Sensitivity and specificity rates of the ICG guided neoplastic disease identification
Study description-13 characters
[...] ld imaged by Iridium system optimized for detection of ICG (VisionsenseEleVision™ Corp,IR Philadelphia, PAPlatform). The entire procedure will be photo- documented and recorded. The VisionsenseEleVision™ system records images in real time, calculates percentages, [...]
Study sitescontacts updated at 1 of 1 site
2024-08-27
Study Status v16
Re-verified, no change to tracked fields
Show 15 earlier versions
2024-03-22
Study Status v15
Primary completion date2024-12-31→2025-12-31
2023-10-06
2 amendments v13-v14
2 re-verifications since 2023-03-31, no change to tracked fields
2022-07-14
Study Status v12
Primary completion date2022-12-31→2024-12-31
Completion date2022-12-31→2025-12-31
2022-03-11
Study Status, Study Description, Eligibility v11
Eligibility criteria+38 characters
[...] nign pathology. Patients with brain tumors. Pregnant female. Patients with unilateral Wilms Tumor.
2021-06-16
2 amendments v9-v10
2 re-verifications since 2021-03-17, no change to tracked fields
2020-09-16
Active, Not Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Contacts/Locations v8
Trial statusActive, Not Recruiting→Recruiting
Study description-55 characters
[...] included. Indocyanine Green (ICG) is an FDA-approved drug. ThePrior day before theto surgery, patients will receive a single dose of ICG intravenously. Surgery will be performed the following day. During surgery, after the surgeon identifies the mass throug [...]
Study sitesdetails revised at 1 of 1 site
2020-04-27
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2020-02-10
Study Status v6
Start dateestimated 2020-02→confirmed 2020-02-07
2020-02-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start date2020-01→2020-02
Study sitesdetails revised at 1 of 1 site
2019-12-10
Study Status v4
Start date2019-11→2020-01
2019-10-29
Study Status v3
Start date2019-10→2019-11
2019-10-11
Study Status, IPDSharing v2
Re-verified, no change to tracked fields
2019-10-02
Study Status v1
Start date2019-09→2019-10
2019-09-09
Original filing
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
Trial Details
NCT Number NCT04084067
Lead Sponsor St. Jude Children's Research Hospital
Conditions Neoplastic Disease, Solid Tumor
Enrollment 215 participants
Start Date 2020-02-07
Primary Completion 2026-07-28 (estimated)
Study Completion 2026-08-26 (estimated)
Updated on ClinicalTrials.gov 2026-09-14