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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04492735
Other study ID # PSORC ICG
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 5, 2020
Est. completion date June 2025

Study information

Verified date July 2020
Source Children's Hospital Medical Center, Cincinnati
Contact Erin Watters
Phone 513-803-7024
Email erin.watters@cchmc.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date June 2025
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 45 Years
Eligibility 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 Design


Locations

Country Name City State
United States Cincinnati Childrens Hospital Medical Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Roshni Dasgupta

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy using pathologic correlation as gold standard measure 2 years
Primary Short and long term event free and overall survival 2 years
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