Clinical trial NCT04084067: Indocyanine Green (ICG) Guided Tumor Resection
Official title: Indocyanine Green (ICG) Guided Tumor Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Neoplastic Disease
Solid Tumor
Keywords: Ewing Sarcoma
Liver tumor
Lymphoma
Metastatic pulmonary deposits
Neoplastic Disease
Neuroblastoma
Non-Rhabdomyosarcoma Soft Tissue Sarcoma
Nodules of unknown etiology
Osteosarcoma
Solid Tumor
Rhabdomyosarcoma
Renal tumors
Rare tumors
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Sensitivity rates of the ICG guided neoplastic disease identification
timeFrame: up to 24 hours post-surgery
Secondary outcomes:
Other outcomes:
measure: Sensitivity rates of the ICG guided neoplastic disease identification
timeFrame: up to 24 hours post-surgery
measure: Sensitivity and specificity rates of the ICG guided residual (lymph node and tumor bed) neoplastic disease identification
timeFrame: up to 24 hours post-surgery
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Lindsay Talbot, MD
role: PRINCIPAL_INVESTIGATOR
References: