Neoplastic DiseasePhase 1NCT04084067
Indocyanine Green (ICG) Guided Tumor Resection
A Phase 1 study testing Indocyanine Green in people with Neoplastic Disease and Solid Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplastic Disease, Solid Tumor
- What is being tested?
- Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2020to 26 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.
Who cannot join
- Subjects with a history of iodide allergies.
- 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.
- Patients with unilateral Wilms Tumor.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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
Read more
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:
- Osteosarcoma
- Neuroblastoma
- Metastatic pulmonary deposits - closed to accrual
Exploratory Objectives
- To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated.
- Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback.
- Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging.
- 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:
- Ewing Sarcoma
- Rhabdomyosarcoma (RMS)
- Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
- Renal tumors
- Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology
Read the 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. Prior to surgery, patients will receive a single dose of ICG intravenously.
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 (EleVision™ IR Platform). The entire procedure will be photo- documented and recorded.
The EleVision™ 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.
- Conditions
- Neoplastic Disease, Solid Tumor
- Being tested
- Indocyanine Green
- Keywords
- 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
- Medical subject headings
- Neoplasms, Sarcoma, Ewing, Carcinoma, Hepatocellular, Lymphoma, Neuroblastoma, Sarcoma, Osteosarcoma, Rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called IC-GREEN™, ICG
IV
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine green (ICG) | Experimental | Participants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes prior to surgery. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity rates of the ICG guided neoplastic disease identification
Participants in each of the primary objective categories will be evaluated for this objective.
Measured: up to 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start7 Feb 2020
- Primary completion28 Jul 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplastic DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lindsay Talbot, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084067
- Sponsor's protocol ID
- ICGLOW
- Other IDs
- NCI-2019-06146
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2019
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Abdelhafeez AH, Mothi SS, Pio L, Mori M, Santiago TC, McCarville MB, Kaste SC, Pappo AS, Talbot LJ, Murphy AJ, Davidoff AM. Feasibility of indocyanine green-guided localization of pulmonary nodules in children with solid tumors. Pediatr Blood Cancer. 2023 Oct;70(10):e30437. doi: 10.1002/pbc.30437. Epub 2023 May 17.
PubMed 37194488
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indocyanine Green (ICG) Guided Tumor Resection
- ClinicalTrials.gov ID
- NCT04084067
- Acronym / sponsor ID
- ICGLOW
- Conditions
- Neoplastic Disease, Solid Tumor
- Keywords
- Ewing Sarcoma, Liver tumor, Lymphoma, Metastatic pulmonary deposits, Neoplastic Disease, Neuroblastoma, Non-Rhabdomyosarcoma Soft Tissue Sarcoma, Nodules of unknown etiology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Osteosarcoma
- Neuroblastoma
- Metastatic pulmonary deposits - closed to accrual
Exploratory Objectives
- To compare the ICG uptake by primary vs metastatic site and pre-treated (chemotherapy, radiation, or both) vs non-pre-treated.
- Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified by standard of care intraoperative inspection and tactile feedback.
- Assess the sensitivity and specificity of NIR imagery to find additional lesions not identified on preoperative diagnostic imaging.
- 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:
- Ewing Sarcoma
- Rhabdomyosarcoma (RMS)
- Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
- Renal tumors
- Liver tumors, lymphoma, other rare tumors, and nodules of unknown etiology
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. Prior to surgery, patients will receive a single dose of ICG intravenously.
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 (EleVision™ IR Platform). The entire procedure will be photo- documented and recorded.
The EleVision™ 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine green (ICG) | Experimental | Drug: Indocyanine GreenParticipants will receive a single dose of 1.5 mg/kg of ICG intravenously over 15 minutes prior to surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a primary or relapsed solid tumor or lymphoma who require excision of the tumor or metastatic lesions.
Key exclusion criteria (6 listed)
- Subjects with a history of iodide allergies.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine GreenAlso: IC-GREEN™, ICGIV | Drug | Indocyanine green (ICG) |
Primary outcome
Sensitivity rates of the ICG guided neoplastic disease identification
Time frame: up to 24 hours post-surgery
Participants in each of the primary objective categories will be evaluated for this objective.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Derived from this study: PubMed 37194488Abdelhafeez AH, Mothi SS, Pio L, Mori M, Santiago TC, McCarville MB, Kaste SC, Pappo AS, Talbot LJ, Murphy AJ, Davidoff AM. Feasibility of indocyanine green-guided localization of pulmonary nodules in children with solid tumors. Pediatr Blood Cancer. 2023 Oct;70(10):e30437. doi: 10.1002/pbc.30437. Epub 2023 May 17.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- ClinicalTrials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay Talbot, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Indocyanine Green in people with Neoplastic Disease and Solid Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity rates of the ICG guided neoplastic disease identification (time frame: up to 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084067, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.