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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04492735
Enrollment
45
Registered
2020-07-30
Start date
2020-06-05
Completion date
2025-06-30
Last updated
2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Disease, Primary Tumor, Solid Malignancies

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

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

Interventions

None listed

Sponsors

Roshni Dasgupta
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Diagnostic accuracy using pathologic correlation as gold standard measure2 years
Short and long term event free and overall survival2 years

Countries

United States

Contacts

Primary ContactErin Watters
erin.watters@cchmc.org513-803-7024

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026