The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies

The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid

Use of indocyanine green will augment the accuracy of identification and resection of both primary solid malignancies as well as their pulmonary metastases, where applicable We will conduct a prospective feasibility study of pediatric patients with solid malignancies with or without lung metastatases who present at the time of initial diagnosis or relapse. These patients will receive a targeted dye to aid in the resection of these metastases. We plan to assess ICG as it relates to:

1. Diagnostic accuracy using pathologic correlation as gold standard measure
2. Short and long term event free and overall survival

Study Overview

• Status: Recruiting
• Conditions: Solid Malignancies; Metastatic Disease; Primary Tumor

Detailed Description

Patients diagnosed with solid malignancies or metastatic lesions who require clinically indicated resection will be identified by their Oncologist. The oncologist will inform the subject/family about the study and ask if they may be interested in participating. If the subject/family demonstrates potential interest in the study, the Pediatric Surgery Research team will discuss the risks and benefits of pre-operative ICG administration with the patients and enrollment.

Study subjects: All patients diagnosed with solid malignancies as well as those with metastatic disease distant from the primary tumor will be potentially eligible for the study. Diagnosis will be made:

1. In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI, CT scan, etc), and sometimes biopsy.
2. Prior to definitive surgical resection of the newly diagnosed malignancy

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Erin Watters; Phone Number: 513-803-7024; Email: erin.watters@cchmc.org

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Childrens Hospital Medical Center
      • Contact: Erin Watters; Phone Number: 513-803-7024; Email: erin.watters@cchmc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Oncology solid, primary malignancies or their related metastatic lesion

Description

Inclusion Criteria:

All patients with newly diagnosed solid, primary malignancies or their related metastatic lesions.

Diagnosis of primary or metastatic malignancy will be made by combination of:

1. Clinical evaluation and physical exam
2. Radiologic study including ultrasound, CT scan, and/or MRI
3. Pathologic diagnosis after biopsy

Exclusion Criteria:

1. Those patients and parents/guardians unwilling to provide consent/assent.
2. Pregnant and/or women who are breast feeding.
3. Patients with Iodine allergies

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy using pathologic correlation as gold standard measure	2 years
Short and long term event free and overall survival	2 years

Collaborators and Investigators

• Sponsor: Roshni Dasgupta

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplastic Processes; Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: PSORC ICG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No