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Indocyanine Green (ICG) Guided Tumor Resection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084067
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief Summary:

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. Ewing Sarcoma
  3. Rhabdomyosarcoma (RMS)
  4. Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
  5. Neuroblastoma
  6. Renal tumors
  7. Metastatic pulmonary deposits
  8. Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology

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.

Condition or disease Intervention/treatment Phase
Neoplastic Disease Solid Tumor Drug: Indocyanine Green Phase 1

Detailed Description:

This trial is a single center open-label study. Patients with a solid tumor or lymphoma who require resection either for therapeutic or diagnostic intent will be included.

Indocyanine Green (ICG) is an FDA-approved drug. The day before the surgery, patients will receive a single dose of ICG intravenously. Surgery will be performed the following day.

During surgery, after the surgeon identifies the mass through visual (seen with the naked eye) and or tactile methods (palpated), the patient will have his/her tumor field imaged by Iridium system optimized for detection of ICG (Visionsense Corp, Philadelphia, PA). The entire procedure will be photo- documented and recorded.

The Visionsense system records images in real time, calculates percentages, and captures the data. At least three different areas of the tumor will be measured. If the tumor cannot be identified by visual inspection or palpation, NIR-imaging will be used in an attempt to locate the lesion. The surrounding area will be inspected and measured to screen for additional sites of metastatic disease. After tumor resection, residual fluorescence in the surgical resection bed will be measured.

Direct subject participation in the trial will last for the period of time from injection of the ICG the day before surgery and until 24 hours post-surgery.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Indocyanine Green (ICG) Guided Tumor Resection
Actual Study Start Date : February 7, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: Indocyanine green (ICG)
Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes the day before surgery.
Drug: Indocyanine Green
IV
Other Names:
  • IC-GREEN™
  • ICG




Primary Outcome Measures :
  1. Sensitivity and specificity rates of the ICG guided neoplastic disease identification [ Time Frame: up to 24 hours post-surgery ]
    The 312 patients (39 patients in each of the 8 categories) will be evaluated for this objective.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.

Exclusion Criteria:

  • Subjects with a history of iodide allergies, including positive allergic reaction to the screening iodine test.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
  • Patients with benign pathology.
  • Patients with brain tumors.
  • Pregnant female.

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): NCT04084067


Contacts
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Contact: Abdelhafeez Abdelhafeez, MD 866-278-5833 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Abdelhafeez Abdelhafeez, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Abdelhafeez Abdelhafeez, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Abdelhafeez Abdelhafeez, MD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT04084067    
Other Study ID Numbers: ICGLOW
NCI-2019-06146 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be made available at the time of article publication.
Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
Rhabdomyosarcoma
Ewing Sarcoma
Liver tumor
Lymphoma
Metastatic pulmonary deposits
Neoplastic Disease
Neuroblastoma
Non-Rhabdomyosarcoma Soft Tissue Sarcoma
Nodules of unknown etiology
Osteosarcoma
Solid Tumor
Renal tumors
Rare tumors
Additional relevant MeSH terms:
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Neoplasms