Tumor, SolidPhase 1/2NCT04723810
TumorGlow Intraoperative Molecular Imaging (IMI)
A Phase 1/2 study testing Indocyanine Green in people with Tumor, Solid, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid
- 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
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2024to 14 Jan 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 18 years of age or older.
- Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment.
- Good operative candidate as determined by the treating physician and/or multidisciplinary team.
- Subject capable of giving informed consent.
Who cannot join
- Subject unable to participate in the consent process.
- Vulnerable population including pregnant women, prisoners, and children.
- History of uncontrolled hypertension (e.g., history of an ER admission for hypertensive crisis or ≥ 3 blood pressure medications)
- Patients with a self-reported history of iodide allergies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Azra Din, MPH, 215-615-7980, azra.din@pennmedicine.upenn.edu
azra.din@pennmedicine.upenn.edu
About this study
Official title: A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)
This is a Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using indocyanine green for intramolecular imaging of solid tumors.
- Conditions
- Tumor, Solid
- Being tested
- Indocyanine Green
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
The investigational drug is indocyanine green, single dose between 1-5 mg/kg diluted into sterile water for intravenous (IV) injection up to 5 days prior to resection surgery. The actual dose and timing from dose to imaging will be determined based on tumor type.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has not been fully studied will be enrolled: glioma, breast cancer, colon cancer, rectal cancer, head and neck cancer, pulmonary metastasectomy (colorectal mets), thymoma, ovarian cancer, prostate cancer, renal cell carcinoma, thyroid cancer, parathyroid adenoma, mesothelioma, esophageal cancer, pancreas cancer, stomach cancer. Receives: Drug: Indocyanine Green |
| Cohort 2 | Experimental | Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has been fully studied will be enrolled: non-small cell lung cancer, metastatic sarcoma to the lung, brain meningioma. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Determine the safety of indocyanine green (all tumor types combined)
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
Measured: Up to 5 days
Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)
Dosing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
Measured: Up to 5 days
Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)
Timing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
Measured: Up to 5 days
Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)
Nodule/lesion-level and subject-level sensitivity and specificity of TumorGlow (tumor type-specific).
- Sensitivity of indocyanine green = TP/(TP+FN) = (# that fluoresce and are cancer)/(# that are cancer)
- Specificity of indocyanine green = TN/(TN+FP) = (# that not cancer and do not fluoresce)/(# that are not cancer)
Measured: Up to 5 days
Cohort 2: Confirm the efficacy of indocyanine green used with Near Infrared (NIR) fluorescent imaging as measured by Clinically Significant Event (CSE) rate (tumor type-specific)
Clinically Significant Event (CSE) rate (tumor type-specific). A CSE includes any of the following event:
- One or more primary nodule (cancerous or non-cancerous) not detected under normal light and/or palpation but is detected by imaging,
- One or more cancerous synchronous lesion not detected under normal light and/or palpation but is detected by imaging,
- The identification of a cancer positive margin that fluoresces within (less than or equal to) 5 mm of the surgical margin.
Measured: Up to 5 days
Secondary outcomes (3)
Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific)
Nodule/lesion-level and subject-level sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific).
Measured: Up to 5 days
Cohort 1: Provide preliminary estimate of the efficacy of indocyanine green for locating additional cancers and missed surgical margins as measured by CSE rate (tumor type-specific)
Clinically Significant Event (CSE) rate (tumor type-specific).
Measured: Up to 5 days
Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
Measured: Up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start14 Aug 2024
- Primary completion14 Jan 2027 (estimated)
- Study completion14 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor, SolidStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723810
- Sponsor's protocol ID
- 844554
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2021
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)
- ClinicalTrials.gov ID
- NCT04723810
- Acronym / sponsor ID
- 844554
- Conditions
- Tumor, Solid
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 14 Jan 2027 (estimated)
- Study completion
- 14 Jan 2027 (estimated)
- First posted
- 26 Jan 2021 (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 Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using indocyanine green for intramolecular imaging of solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Indocyanine GreenPatients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has not been fully studied will be enrolled: glioma, breast cancer, colon cancer, rectal cancer, head and neck cancer, pulmonary metastasectomy (colorectal mets), thymoma, ovarian cancer, prostate cancer, renal cell carcinoma, thyroid cancer, parathyroid adenoma, mesothelioma, esophageal cancer, pancreas cancer, stomach cancer. |
| Cohort 2 | Experimental | Drug: Indocyanine GreenPatients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has been fully studied will be enrolled: non-small cell lung cancer, metastatic sarcoma to the lung, brain meningioma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients 18 years of age or older.
- Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment.
- Good operative candidate as determined by the treating physician and/or multidisciplinary team.
- Subject capable of giving informed consent.
Key exclusion criteria (4 listed)
- Subject unable to participate in the consent process.
- Vulnerable population including pregnant women, prisoners, and children.
- History of uncontrolled hypertension (e.g., history of an ER admission for hypertensive crisis or ≥ 3 blood pressure medications)
- Patients with a self-reported history of iodide allergies.
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 GreenThe investigational drug is indocyanine green, single dose between 1-5 mg/kg diluted into sterile water for intravenous (IV) injection up to 5 days prior to resection surgery. The actual dose and timing from dose to imaging will be determined based on tumor type. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Cohort 1: Determine the safety of indocyanine green (all tumor types combined)
Time frame: Up to 5 days
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)
Time frame: Up to 5 days
Dosing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)
Time frame: Up to 5 days
Timing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)
Time frame: Up to 5 days
Nodule/lesion-level and subject-level sensitivity and specificity of TumorGlow (tumor type-specific). * Sensitivity of indocyanine green = TP/(TP+FN) = (# that fluoresce and are cancer)/(# that are cancer) * Specificity of indocyanine green = TN/(TN+FP) = (# that not cancer and do not fluoresce)/(# that are not cancer)
Cohort 2: Confirm the efficacy of indocyanine green used with Near Infrared (NIR) fluorescent imaging as measured by Clinically Significant Event (CSE) rate (tumor type-specific)
Time frame: Up to 5 days
Clinically Significant Event (CSE) rate (tumor type-specific). A CSE includes any of the following event: * One or more primary nodule (cancerous or non-cancerous) not detected under normal light and/or palpation but is detected by imaging, * One or more cancerous synchronous lesion not detected under normal light and/or palpation but is detected by imaging, * The identification of a cancer positive margin that fluoresces within (less than or equal to) 5 mm of the surgical margin.
3 secondary outcomes
Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific)
Time frame: Up to 5 days
Cohort 1: Provide preliminary estimate of the efficacy of indocyanine green for locating additional cancers and missed surgical margins as measured by CSE rate (tumor type-specific)
Time frame: Up to 5 days
Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)
Time frame: Up to 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Indocyanine Green in people with Tumor, Solid, run by University of Pennsylvania 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Mar 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azra Din (215-615-7980, azra.din@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: Determine the safety of indocyanine green (all tumor types combined) (time frame: Up to 5 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026.