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

NCT04492735 | Unknown

• 1 other identifier: PSORC ICG
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Disease; Primary Tumor; Solid Malignancies

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy using pathologic correlation as gold standard measure

  2 years

• Short and long term event free and overall survival

  2 years

Eligibility Criteria

• Age: 1 Day - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Oncology solid, primary malignancies or their related metastatic lesion

You may qualify if:

• 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:
• Clinical evaluation and physical exam
• Radiologic study including ultrasound, CT scan, and/or MRI
• Pathologic diagnosis after biopsy

You may not qualify if:

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

Sponsors & Collaborators

• Roshni Dasgupta: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erin Watters

CONTACT

513-803-7024; erin.watters@cchmc.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Roshni Dasgupta, MD

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: June 5, 2020
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2025
• Last Updated: July 30, 2020

Record last verified: 2020-07

Locations

US (1)