RECRUITING

Indocyanine Green (ICG) Guided Tumor Resection

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a study to assess the ability of Indocyanine Green (ICG) to identify neoplastic disease. For many pediatric solid tumors, complete resection of the primary site and/or metastatic deposits is critical for achieving a cure. An optimal intra-operative tool to help visualize tumor and its margins would be of benefit. ICG real-time fluorescence imaging is a technique being used increasingly in adults for this purpose. We propose to use it during surgery for pediatric malignancies. All patients with tumors that require localization for resection or biopsy of the tumor and/or metastatic lesions will be eligible. Primary Objective To assess the feasibility of Indocyanine Green (ICG)-mediated near-infrared (NIR) imagery to identify neoplastic disease during the conduct of surgery to resect neoplastic lesions in children and adolescents. NIR imaging will be done at the start of surgery to assess NIR-positivity of the lesion(s) and at the end of surgery to assess completeness of resection. Separate assessments will be made for the following different histologic categories: 1. Osteosarcoma 2. Neuroblastoma 3. Metastatic pulmonary deposits - closed to accrual Exploratory Objectives 1. To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated. 2. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback. 3. Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging. 4. Assess the sensitivity and specificity of NIR imagery for identifying residual disease at the conclusion of a tumor resection. Separate assessments will be made for the following different histologic categories based on their actual enrollment; this includes but is not limited to analyzing multiple arms together: 1. Ewing Sarcoma 2. Rhabdomyosarcoma (RMS) 3. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) 4. Renal tumors 5. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

Official Title

Indocyanine Green (ICG) Guided Tumor Resection

Quick Facts

Study Start:2020-02-07
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04084067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.
  1. * Subjects with a history of iodide allergies.
  2. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  3. * Patients with benign pathology.
  4. * Patients with brain tumors.
  5. * Pregnant female.
  6. * Patients with unilateral Wilms Tumor.

Contacts and Locations

Study Contact

Lindsay Talbot, MD
CONTACT
866-278-5833
referralinfo@stjude.org

Principal Investigator

Lindsay Talbot, MD
PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

  • Lindsay Talbot, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-07
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2020-02-07
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Ewing Sarcoma
  • Liver tumor
  • Lymphoma
  • Metastatic pulmonary deposits
  • Neoplastic Disease
  • Neuroblastoma
  • Non-Rhabdomyosarcoma Soft Tissue Sarcoma
  • Nodules of unknown etiology
  • Osteosarcoma
  • Solid Tumor
  • Rhabdomyosarcoma
  • Renal tumors
  • Rare tumors

Additional Relevant MeSH Terms

  • Neoplastic Disease
  • Solid Tumor