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

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    45
  • sponsor
    Roshni Dasgupta
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Updated on 5 August 2020
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cancer
ct scan
metastasis
metastatic malignancy
pulmonary metastasis

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

Details
Condition Metastasis, Brain Metastases, Liver Metastases, neoplasm metastasis, Brain Metastases, Liver Metastases, neoplasm metastasis, Primary Tumor, Solid Malignancies
Age 45years or below
Clinical Study IdentifierNCT04492735
SponsorRoshni Dasgupta
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

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

Exclusion Criteria

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