Recruiting

Indocyanine Green

Sponsor:

Roshni Dasgupta

Code:

NCT04492735

Conditions

Metastatic Disease

Primary Tumor

Solid Malignancies

Eligibility Criteria

Sex: All

Age: 0 - 45

Healthy Volunteers: Not accepted

Study Details

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

Conditions

Metastatic Disease

Primary Tumor

Solid Malignancies

Study ID

NCT04492735

Start date

Jun 5, 2020

Status verified date

Jul, 2020

Completion date

Jun, 2025

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 45

Healthy Volunteers: Not accepted

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

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Diagnostic accuracy using pathologic correlation as gold standard measure [ Time Frame: 2 years ]
  • Short and long term event free and overall survival [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Erin Watters

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

Locations

Cincinnati Childrens Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Erin Watters

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

More Information

Sponsor

Roshni Dasgupta

Last update posted

Jul 30, 2020

Last verified

Jul, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roshni Dasgupta on 2020-07-30.