Bone SarcomaNCT06409013
Evaluation of Tumor Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography in Patients With Sarcoma
An observational study of Bone Sarcoma and Soft Tissue Sarcoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Sarcoma, Soft Tissue Sarcoma
- What is being tested?
- Non-Interventional Study
- Type of treatment
- Injection or infusion
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to 30 Mar 2027
- Phase
- Observational
- 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
Study population: Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection recruited through Mayo Clinic
Who may be able to join
- Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection
Who cannot join
- Chronic kidney disease
- Anaphylaxis to dyes
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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Laura Dohrmann, 507-266-5886, Beinborn.Laura@mayo.edu
About this study
Official title: Sarcoma Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography
This study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the use of indocyanine green (ICG) as an intraoperative guide during bone and soft tissue sarcoma resection.
OUTLINE: This is an observational study.
Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Bone Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of intraoperative ICG fluorescence compared to final pathology results
Intraoperative ICG fluorescence and deduced margins will be analyzed and compared the accuracy to final pathology margins. Negative predictive value will be calculated.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start14 Mar 2024
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone SarcomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew T. Houdek, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409013
- Sponsor's protocol ID
- 23-003589
- Other IDs
- NCI-2024-03482
- Status last verified
- Jul 2026
- First submitted
- 7 May 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcoma Resection Guided by Intraoperative Indocyanine Green Dye Fluorescence Angiography
- ClinicalTrials.gov ID
- NCT06409013
- Acronym / sponsor ID
- 23-003589
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 10 May 2024 (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 study evaluates the effectiveness of intraoperative indocyanine green dye and fluoroscopic technology in confirming negative margins after tumor removal.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the use of indocyanine green (ICG) as an intraoperative guide during bone and soft tissue sarcoma resection.
OUTLINE: This is an observational study.
Patients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients receive ICG infusion prior to undergoing scheduled resection and have medical records reviewed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection recruited through Mayo Clinic
Key inclusion criteria (1 listed)
- Patients with biopsy-proven bone or soft tissue sarcoma undergoing resection
Key exclusion criteria (2 listed)
- Chronic kidney disease
- Anaphylaxis to dyes
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Accuracy of intraoperative ICG fluorescence compared to final pathology results
Time frame: Baseline
Intraoperative ICG fluorescence and deduced margins will be analyzed and compared the accuracy to final pathology margins. Negative predictive value will be calculated.
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 4 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Matthew T. Houdek, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Sarcoma and Soft Tissue Sarcoma, run by Mayo Clinic 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 2 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 4 Aug 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.
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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of intraoperative ICG fluorescence compared to final pathology results (time frame: Baseline). 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 4 Aug 2026.