Soft Tissue Sarcoma of the Trunk and ExtremitiesFOCUSNCT07134192
Fluorescence-Guided Optimization of Sarcoma Margins
A study testing Fluorescent-guided Surgery in people with Soft Tissue Sarcoma of the Trunk and Extremities and Sarcoma, run by University of Aarhus at 2 sites in Denmark.
Trial summary
This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma of the Trunk and Extremities, Sarcoma
- What is being tested?
- Fluorescent-guided Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Sep 2025to 1 Mar 2028
- Phase
- Interventional
- 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
- Biopsy verified intermediate-to-high grade sarcoma of theextremity or trunk wall
- Age>18 years old
- Tumor operable
- Curative intent at time of surgery
- Consent of patient
Who cannot join
- History of allergic reaction to iodine-containing pharmaceuticals
- End-stage renal disease or eGFR <15
- Patient decision
- Lack of capacity
- Inoperability
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Christian Kveller, MD, +45 51 48 13 19, chrkve@rm.dk
Thomas Baad-Hansen, MD, PhD, +45 28603490, thombaad@rm.dk
- Recruiting
Rigshospitalet
Copenhagen, 2100
Michael M Petersen, MD, PhD, +45 3545 8900, Michael.Moerk.Petersen@regionh.dk
Michael M Petersen, MD, PhD
About this study
This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.
Read the detailed description
This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.
Biopsy verified intermediate-to-high grade sarcoma of the extremity or trunk wall are eligible for inclusion. To be included there must be curative intent at time of surgery.
The primary endpoint will be re-resection within 30 days due to positive margins on the initial resection. Tumor characteristics and margin status from pathology reports will be recorded. Data on reoperations due to other factors, positive margins without planned reoperation, or death will also be collected. Participants will undergo surgery with ICG administered and guided using the SPY-PHI.
The prospective cohort will be compared to a historic cohort having received standard of care treatment. The historic cohort is included to act as a control group to compare with the new procedure. The data is derived from the Danish Sarcoma Database and permissions for this is in process. This data does not involve access to patient EMRs.
Patients will receive an intravenous bolus of 1 mg/kg fluorescent ICG dye 2-24 hours before surgery. During surgery, consecutive measurements will be recorded using the SPY-PHI. Surgical resection will be guided by the fluorescent signal. The wound bed will be inspected, areas with fluorescent signal will be excised and obtained separately for histopathology. Patients will receive the current post-operative standard of care for sarcoma patients.
Approximately 20 minutes of additional surgical time is expected.
- Being tested
- Fluorescent-guided Surgery
- Keywords
- Sarcoma, ICG, Indocyanine green, Fluorescence Guided Surgery, FGS, STS, Soft Tissue Sarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescent-guided SurgeryProcedure or surgery
Surgical treatment of the patient group will include the administration of a fluorescent dye and intraoperatively the resection will be aided and guided by the fluorescent signal. The wound bed will be inspected, areas with fluorescent signal will be excised and obtained separately for histopathology. Patients will receive the current post-operative standard of care for sarcoma patients
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence-guided surgery cohort | Experimental | Patients with intermediate-to-high grade sarcomas eligible for curative surgical treatment at time of surgery. Surgery will be augmented by guidance through the use of a near-infrared camera and fluorescent dye administered hours prior to surgery. Receives: Procedure: Fluorescent-guided Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reresection
Reresection within 30 days will be used as primary endpoint as a proxy for histopathologically positive margin status following surgery which would require reoperation.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma of the Trunk and ExtremitiesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- National multicenter interventional cohort study
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Baad-Hansen, MD, PhD, Principal investigator, Orthopedic Surgical Department, Aarhus University HospitalChristian Kveller, MD, Study director, Orthopedic Surgical Department, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134192
- Sponsor's protocol ID
- 113942
- Other IDs
- 1-10-72-34-25
- Acronym
- FOCUS
- Status last verified
- Jul 2025
- First submitted
- 13 Aug 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence-Guided Optimization of Sarcoma Margins
- ClinicalTrials.gov ID
- NCT07134192
- Acronym / sponsor ID
- FOCUS / 113942
- Keywords
- Sarcoma, ICG, Indocyanine green, Fluorescence Guided Surgery, FGS, STS, Soft Tissue Sarcoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 21 Aug 2025 (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 Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.
Detailed description
This is a Danish national multicenter prospective cohort study to evaluate if fluorescence-guided surgery (FGS) using indocyanine green (ICG) can reduce the rate of positive margins following sarcoma resection.
Biopsy verified intermediate-to-high grade sarcoma of the extremity or trunk wall are eligible for inclusion. To be included there must be curative intent at time of surgery.
The primary endpoint will be re-resection within 30 days due to positive margins on the initial resection. Tumor characteristics and margin status from pathology reports will be recorded. Data on reoperations due to other factors, positive margins without planned reoperation, or death will also be collected. Participants will undergo surgery with ICG administered and guided using the SPY-PHI.
The prospective cohort will be compared to a historic cohort having received standard of care treatment. The historic cohort is included to act as a control group to compare with the new procedure. The data is derived from the Danish Sarcoma Database and permissions for this is in process. This data does not involve access to patient EMRs.
Patients will receive an intravenous bolus of 1 mg/kg fluorescent ICG dye 2-24 hours before surgery. During surgery, consecutive measurements will be recorded using the SPY-PHI. Surgical resection will be guided by the fluorescent signal. The wound bed will be inspected, areas with fluorescent signal will be excised and obtained separately for histopathology. Patients will receive the current post-operative standard of care for sarcoma patients.
Approximately 20 minutes of additional surgical time is expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- National multicenter interventional cohort study
| Arm | Type | Receives |
|---|---|---|
| Fluorescence-guided surgery cohort | Experimental | Procedure: Fluorescent-guided SurgeryPatients with intermediate-to-high grade sarcomas eligible for curative surgical treatment at time of surgery. Surgery will be augmented by guidance through the use of a near-infrared camera and fluorescent dye administered hours prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy verified intermediate-to-high grade sarcoma of theextremity or trunk wall
- Age>18 years old
- Tumor operable
- Curative intent at time of surgery
- Consent of patient
Key exclusion criteria (5 listed)
- History of allergic reaction to iodine-containing pharmaceuticals
- End-stage renal disease or eGFR <15
- Patient decision
- Lack of capacity
- Inoperability
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 |
|---|---|---|
| Fluorescent-guided SurgerySurgical treatment of the patient group will include the administration of a fluorescent dye and intraoperatively the resection will be aided and guided by the fluorescent signal. The wound bed will be inspected, areas with fluorescent signal will be excised and obtained separately for histopathology. Patients will receive the current post-operative standard of care for sarcoma patients | Procedure or surgery | Fluorescence-guided surgery cohort |
Primary outcome
Reresection
Time frame: 30 days
Reresection within 30 days will be used as primary endpoint as a proxy for histopathologically positive margin status following surgery which would require reoperation.
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 1 Jul 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.
Thomas Baad-Hansen, MD, PhD principal investigator
Orthopedic Surgical Department, Aarhus University Hospital
Christian Kveller, MD study director
Orthopedic Surgical Department, Aarhus University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescent-guided Surgery in people with Soft Tissue Sarcoma of the Trunk and Extremities and Sarcoma, run by University of Aarhus at 2 sites in Denmark.
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 5 inclusion and 5 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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.
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 Christian Kveller, MD (+45 51 48 13 19, chrkve@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reresection (time frame: 30 days). 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 1 Jul 2026.