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

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ClinicalTrials.gov Identifier: NCT04492735
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Roshni Dasgupta, Children's Hospital Medical Center, Cincinnati

Study Description
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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

Condition or disease
Metastatic Disease Primary Tumor Solid Malignancies

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 Design
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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid
Actual Study Start Date : June 5, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2025
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic accuracy using pathologic correlation as gold standard measure [ Time Frame: 2 years ]
  2. Short and long term event free and overall survival [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   1 Day to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Oncology solid, primary malignancies or their related metastatic lesion
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492735


Contacts
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Contact: Erin Watters 513-803-7024 erin.watters@cchmc.org

Locations
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United States, Ohio
Cincinnati Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Erin Watters    513-803-7024    erin.watters@cchmc.org   
Sponsors and Collaborators
Roshni Dasgupta
More Information
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Responsible Party: Roshni Dasgupta, Roshni Dasgupta, MD, Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04492735    
Other Study ID Numbers: PSORC ICG
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes