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NCT04084067 · ClinicalTrials.gov registry record · Phase 1
Indocyanine Green (ICG) Guided Tumor Resection
A Phase 1 study of Solid Tumor and Neoplastic Disease, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 230
- Enrollment target
- 1
- Study location
NCT04084067 is a Phase 1 study of Solid Tumor and Neoplastic Disease that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 230 participants, roughly in line with the 220-participant average among 196 other Solid Tumor trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT04084067, a Phase 1 study of Solid Tumor and Neoplastic Disease, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 230 participants
- Enrollment target
- 1
- Study location
Study 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. N
Conditions Studied
Interventions
- DRUG Indocyanine Green
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2020-02-07 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04084067
The ClinicalTrials.gov registry entry for NCT04084067 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 220-participant average among 196 other Solid Tumor trials with a reported enrollment target. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which Indocyanine Green is the first listed.
NCT04084067 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT04084067 about?
NCT04084067 is a clinical study titled "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 margin...
What is the current status of trial NCT04084067?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 230 participants. The study started on 2020-02-07. Estimated completion is 2027-12-31.
What conditions does trial NCT04084067 study?
This clinical trial studies the following conditions: Solid Tumor, Neoplastic Disease.
What interventions are being tested in trial NCT04084067?
The interventions under investigation include: Indocyanine Green (DRUG).
Who is sponsoring clinical trial NCT04084067?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04084067 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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