SarcomaPhase 2ICGTMNCT04719156
Fluorescent Intra-operative Tumor Margin Examination
A Phase 2 study testing Indocyanine green solution administered at 2.0mg/kg. and Stryker SPY-PHI Imaging Device in people with Sarcoma, run by Kurt Weiss at 1 site in United States.
Trial summary
Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- Indocyanine green solution administered at 2.0mg/kg. and Stryker SPY-PHI Imaging Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 31 Dec 2026
- Phase
- Phase 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above the age of 18 with a primary musculoskeletal tumor that has been indicated for surgical excision by a fellowship trained orthopaedic oncologist.
- Surgical consent was obtained prior to research consent.
- Patients with a biopsy-confirmed primary soft tissue or bone tumor that has not been previously excised and has a known risk of local or remote recurrence.
Who cannot join
- Patients below the age of 18
- Pregnancy, breast feeding
- Patients with a history of anaphylactic reaction to contrast media or fluorescein allergy
- Prior surgery local to the mass being excised
- Non- or minimally-recurrent masses (i.e. osteochondroma)
- Dialysis, renal failure, uremia
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
UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania, 15213
Beata Krawczyk, MS, 412-802-4100
About this study
Official title: Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery. The investigators hypothesize that ICG will be able to accurately identify residual positive tumor margins during sarcoma excision procedures.
Read the detailed description
Experimental Design:
- A physician investigator will obtain consent during the pre-operative appointment. Study team members may assist with the discussion.
- Upon arrival to the pre-operative area 2 hours prior to surgery, the participant will be injected with 2.0 mg/kg ICG (Indocyanine Green Dye) as per standard protocol: during regular pre-operative work-up, during which a standard of care IV is inserted. The PI or resident physician will administer the injection.
- The participant will undergo the tumor removal surgery as planned pre-operatively. To assess the accuracy and precision of ICG dye localization within tumor, not non-tumor, a small sample of tumor and a small sample of native tissue will be obtained for microscopy analysis (ICG fluorescence is possible on slides following frozen sectioning) 30 seconds, no intra-operative delay.
- Once the tumor is removed to the satisfaction of the surgeon, ICG Angiography (SPY PHI) will be performed to detect any residual signal, 2-3 minutes, no re-draping required. The surgeon will complete a "feedback sheet" that assesses if the tumor was completely excised (or an intentional positive margin was left).
- The operative surgeon will be blinded to the angiography result. ICG Angiography will be performed by the resident or surgical staff, without surgeon involvement. No study team members are blinded.
- The dose that will be administered 2.0 mg/Kg IC. Doses are being based on measurements on post-washout signal (or the remaining signal after the dye is metabolized). Weight based dosing is therefore far more important. The proposed dosing is not close to the LD50 (median lethal dose) of ICG and no side effects are anticipated with the increased dose.
- The Stryker team will be perform an in-service for SPY PHI ( SPY portable hand held imaging device) for all OR staff members, and individual demonstrations for each service resident will be performed. The device is very simple to use and no active measurements need to be made. No extended anesthesia will be required.
- The participant will be monitored for recurrence, which will be compared with ICG angiography findings intra-operatively.
- Study efficacy will be evaluated every 6 months, as early-termination and clinical translation will be indicated should accuracy be proven in compliance with IRB (Institutional Review Board) "do no harm" rules.
- Radiographs, that are completed post operatively during the standard of care visit, will be reviewed for this research.
- Conditions
- Sarcoma
- Being tested
- Indocyanine green solution administered at 2.0mg/kg., Stryker SPY-PHI Imaging Device
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green solution administered at 2.0mg/kg.Drug
Also called Indocyanine Green for Injection
Dosing of ICG to be administered at 2.0mg/kg, two hours prior to surgery.
Stryker SPY-PHI Imaging DeviceDevice
Also called Stryker SPY portable Imaging System
The SPY-PHI system is used with the ICG dye to provide fluorescence images.
| Study group | Role | What they receive |
|---|---|---|
| ICG use followed by SPY-PHI imaging. | Other | Participants will be injected with 2.0mg/kg of ICG dye to access tumor margin using Stryker SPY imaging technology. Receives: Drug: Indocyanine green solution administered at 2.0mg/kg.; Device: Stryker SPY-PHI Imaging Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor recurrence as predicted by the surgeon vs. identified with SPY.
The proportion of tumors declared "completely removed" by the surgeon that recur locally will be compared those with SPY-identified residual disease.
Measured: During surgery for tumor removal
Secondary outcomes (1)
Comparison of ICG angiography with pathologic evaluation
The ICG signal accessed at the time of surgery, will be compared with final anatomic pathology in order to discern its degree of accuracy.
Measured: Over a two year follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start2 Mar 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with suspected sarcoma tumors.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kurt Weiss
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor-investigator, Kurt Weiss, University of Pittsburgh
- Investigators
- Kurt E Weiss, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719156
- Sponsor's protocol ID
- STUDY19110051
- Acronym
- ICGTM
- Status last verified
- Feb 2026
- First submitted
- 6 Jan 2021
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
- ClinicalTrials.gov ID
- NCT04719156
- Acronym / sponsor ID
- ICGTM / STUDY19110051
- Conditions
- Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Kurt WeissUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 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.
Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery. The investigators hypothesize that ICG will be able to accurately identify residual positive tumor margins during sarcoma excision procedures.
Detailed description
Experimental Design:
- A physician investigator will obtain consent during the pre-operative appointment. Study team members may assist with the discussion.
- Upon arrival to the pre-operative area 2 hours prior to surgery, the participant will be injected with 2.0 mg/kg ICG (Indocyanine Green Dye) as per standard protocol: during regular pre-operative work-up, during which a standard of care IV is inserted. The PI or resident physician will administer the injection.
- The participant will undergo the tumor removal surgery as planned pre-operatively. To assess the accuracy and precision of ICG dye localization within tumor, not non-tumor, a small sample of tumor and a small sample of native tissue will be obtained for microscopy analysis (ICG fluorescence is possible on slides following frozen sectioning) 30 seconds, no intra-operative delay.
- Once the tumor is removed to the satisfaction of the surgeon, ICG Angiography (SPY PHI) will be performed to detect any residual signal, 2-3 minutes, no re-draping required. The surgeon will complete a "feedback sheet" that assesses if the tumor was completely excised (or an intentional positive margin was left).
- The operative surgeon will be blinded to the angiography result. ICG Angiography will be performed by the resident or surgical staff, without surgeon involvement. No study team members are blinded.
- The dose that will be administered 2.0 mg/Kg IC. Doses are being based on measurements on post-washout signal (or the remaining signal after the dye is metabolized). Weight based dosing is therefore far more important. The proposed dosing is not close to the LD50 (median lethal dose) of ICG and no side effects are anticipated with the increased dose.
- The Stryker team will be perform an in-service for SPY PHI ( SPY portable hand held imaging device) for all OR staff members, and individual demonstrations for each service resident will be performed. The device is very simple to use and no active measurements need to be made. No extended anesthesia will be required.
- The participant will be monitored for recurrence, which will be compared with ICG angiography findings intra-operatively.
- Study efficacy will be evaluated every 6 months, as early-termination and clinical translation will be indicated should accuracy be proven in compliance with IRB (Institutional Review Board) "do no harm" rules.
- Radiographs, that are completed post operatively during the standard of care visit, will be reviewed for this research.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with suspected sarcoma tumors.
| Arm | Type | Receives |
|---|---|---|
| ICG use followed by SPY-PHI imaging. | Other | Drug: Indocyanine green solution administered at 2.0mg/kg., Device: Stryker SPY-PHI Imaging DeviceParticipants will be injected with 2.0mg/kg of ICG dye to access tumor margin using Stryker SPY imaging technology. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients above the age of 18 with a primary musculoskeletal tumor that has been indicated for surgical excision by a fellowship trained orthopaedic oncologist.
- Surgical consent was obtained prior to research consent.
- Patients with a biopsy-confirmed primary soft tissue or bone tumor that has not been previously excised and has a known risk of local or remote recurrence.
Key exclusion criteria (6 listed)
- Patients below the age of 18
- Pregnancy, breast feeding
- Patients with a history of anaphylactic reaction to contrast media or fluorescein allergy
- Prior surgery local to the mass being excised
- Non- or minimally-recurrent masses (i.e. osteochondroma)
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 green solution administered at 2.0mg/kg.Also: Indocyanine Green for InjectionDosing of ICG to be administered at 2.0mg/kg, two hours prior to surgery. | Drug | ICG use followed by SPY-PHI imaging. |
| Stryker SPY-PHI Imaging DeviceAlso: Stryker SPY portable Imaging SystemThe SPY-PHI system is used with the ICG dye to provide fluorescence images. | Device | ICG use followed by SPY-PHI imaging. |
Primary outcome
Tumor recurrence as predicted by the surgeon vs. identified with SPY.
Time frame: During surgery for tumor removal
The proportion of tumors declared "completely removed" by the surgeon that recur locally will be compared those with SPY-identified residual disease.
1 secondary outcome
Comparison of ICG angiography with pathologic evaluation
Time frame: Over a two year follow up period
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 20 Feb 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.
Kurt E Weiss principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indocyanine green solution administered at 2.0mg/kg. and Stryker SPY-PHI Imaging Device in people with Sarcoma, run by Kurt Weiss 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 3 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: looking for participants now, as of the sponsor's last update on 20 Feb 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 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 Beata Krawczyk, krawbx@upmc.edu (412-401-3000, krawbx@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor recurrence as predicted by the surgeon vs. identified with SPY. (time frame: During surgery for tumor removal). 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 20 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.