Bone TumorEarly Phase 1NCT05075889
Utility of ICG in Benign Bone Tumors
A Early Phase 1 study testing Indocyanine Green in people with Bone Tumor, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
Patients with a biopsy-proven benign bone tumor for which standard of care is intralesional operative management will receive a weight-appropriate IV dose of indocyanine green (ICG, FDA-approved) the day prior to surgery during their standard pre-operative clinic visit. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Bone Tumor
- What is being tested?
- Indocyanine Green
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 20 Apr 2022
- Phase
- Early 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects 12 years of age or older
- Diagnosis of any of the following that has been identified by imaging and/or biopsy:
- Enchondroma
- Periosteal chondroma
- Osteochondroma
- Chondroblastoma
Show all 16Show fewer
- Giant cell tumor of bone
- Aneurysmal bone cyst
- Unicameral (aka Simple) bone cyst
- Chondromyxoid fibroma
- Osteoblastoma
- Desmoplastic fibroma
- Fibrous dysplasia
- Osteofibrous dysplasia
- Intralesional operative management for their tumor planned
- Written informed consent signed by the subject if 18 years of age or older or by parent(s) or legally authorized representative if younger than 18 years of age. If younger than 18 years of age, the child must be able to be assent.
Who cannot join
- Iodine allergy
- Women who are pregnant or breastfeeding
- Incarcerated individuals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Study Investigating the Utility of Indocyanine Green (ICG) Fluorescence Imaging in Patients With Benign Bone Tumors Requiring Intralesional Operative Management
Patients with a biopsy-proven benign bone tumor for which standard of care is intralesional operative management will receive a weight-appropriate IV dose of indocyanine green (ICG, FDA-approved) the day prior to surgery during their standard pre-operative clinic visit. On the day of surgery, fluorescence images will be obtained using a non-invasive fluorescence camera.
Read the detailed description
ICG fluorescence imaging has been used to assess tissue perfusion in vivo in real-time intra-operative arterial and lymphatic perfusion imaging and osseous flap perfusion imaging. Compared to the conventional medical imaging modalities, such as computed tomography (CT) or magnetic resonance imaging (MRI), ICG fluorescence imaging is nonionizing, low-cost, and portable. ICG is a dye that absorbs near-infrared light in the wavelength range between 790 to 805 nm and has an emission at the peak of 835 nm. ICG is almost 98% plasma protein-bound so that once it is received in the microcirculation, it remains within the lymphatic and circulatory vasculature unless inflammation is present. ICG has been approved for clinical use by the Food and Drug Administration (FDA) since 1959. Since then, ICG has been used in humans for angiography in ophthalmology and cardiology applications and is given routinely to patients in these clinical settings. ICG fluorescence imaging has also been used to guide laparoscopic surgery, robotic adrenalectomy, assess tissue perfusion in vivo in real-time intra-operative arterial and lymphatic perfusion imaging, and tissue flap perfusion imaging. ICG is ideal to measure perfusion/blood flow because it binds efficiently to blood lipoproteins and thus does not leak from circulation under normal circumstances. In addition, the ICG half-life is short making repeated measures possible, and it is indirectly activated, so that the dynamic fluorescence due to bone and tissue perfusion can be captured by a video rate imaging system.
The dynamic fluorescence imaging systems to be used in this study will be preferentially the Pentero surgical microscope (Zeiss, Germany), Spy Elite Imaging System or SPY Portable Handheld Imaging (SPY-PHI) System (Novadaq/Stryker), or another imager may be used. These imagers are commercially available imaging systems that are used to assess tissue perfusion in real time in the operating room. The systems have a multi-directional imaging arm which contains a near-infrared light source that illuminates the fluorescent agent within the tissues, a high definition (HD) video camera that captures the intensity of fluorescent marker in real-time, and software that allows the user to capture relative and absolute perfusion values within the surgical field. These products are FDA-approved for use to monitor blood flow, plastic surgery, microsurgery, reconstructive surgery, gastrointestinal imaging and coronary bypass surgery.
- Conditions
- Bone Tumor
- Being tested
- Indocyanine Green
- Keywords
- Benign, Operative Management
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG
Enrolled subjects will receive Indocyanine Green administered the day prior to surgery during their standard-of-care preoperative appointment
| Study group | Role | What they receive |
|---|---|---|
| Benign Bone patients | Experimental | Patients with Benign Bone tumors requiring intralesional operative management will be administered immunofluorescent indocyanine green 24 hours prior to surgery, imaging of perfused tissues will be performed at the time of tumor removal. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescent intensity contrast
fluorescence contrast suitable to facilitate fluorescence-guided surgical resection of benign bone tumors (tumor-to-background ratio > 2.0)
Measured: 24 hours post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start11 Nov 2021
- Primary completion20 Apr 2022
- Study completion20 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumorStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the same study drug.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric R. Henderson, Dartmouth-Hitchcock Medical Center
- Investigators
- Eric R Henderson, MD, Principal investigator, Dartmouth-Hithcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075889
- Sponsor's protocol ID
- STUDY02000819
- Status last verified
- Apr 2024
- First submitted
- 30 Sep 2021
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Study Investigating the Utility of Indocyanine Green (ICG) Fluorescence Imaging in Patients With Benign Bone Tumors Requiring Intralesional Operative Management
- ClinicalTrials.gov ID
- NCT05075889
- Acronym / sponsor ID
- STUDY02000819
- Conditions
- Bone Tumor
- Keywords
- Benign, Operative Management
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 20 Apr 2022 (actual)
- First posted
- 13 Oct 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.
Patients with a biopsy-proven benign bone tumor for which standard of care is intralesional operative management will receive a weight-appropriate IV dose of indocyanine green (ICG, FDA-approved) the day prior to surgery during their standard pre-operative clinic visit. On the day of surgery, fluorescence images will be obtained using a non-invasive fluorescence camera.
Detailed description
ICG fluorescence imaging has been used to assess tissue perfusion in vivo in real-time intra-operative arterial and lymphatic perfusion imaging and osseous flap perfusion imaging. Compared to the conventional medical imaging modalities, such as computed tomography (CT) or magnetic resonance imaging (MRI), ICG fluorescence imaging is nonionizing, low-cost, and portable. ICG is a dye that absorbs near-infrared light in the wavelength range between 790 to 805 nm and has an emission at the peak of 835 nm. ICG is almost 98% plasma protein-bound so that once it is received in the microcirculation, it remains within the lymphatic and circulatory vasculature unless inflammation is present. ICG has been approved for clinical use by the Food and Drug Administration (FDA) since 1959. Since then, ICG has been used in humans for angiography in ophthalmology and cardiology applications and is given routinely to patients in these clinical settings. ICG fluorescence imaging has also been used to guide laparoscopic surgery, robotic adrenalectomy, assess tissue perfusion in vivo in real-time intra-operative arterial and lymphatic perfusion imaging, and tissue flap perfusion imaging. ICG is ideal to measure perfusion/blood flow because it binds efficiently to blood lipoproteins and thus does not leak from circulation under normal circumstances. In addition, the ICG half-life is short making repeated measures possible, and it is indirectly activated, so that the dynamic fluorescence due to bone and tissue perfusion can be captured by a video rate imaging system.
The dynamic fluorescence imaging systems to be used in this study will be preferentially the Pentero surgical microscope (Zeiss, Germany), Spy Elite Imaging System or SPY Portable Handheld Imaging (SPY-PHI) System (Novadaq/Stryker), or another imager may be used. These imagers are commercially available imaging systems that are used to assess tissue perfusion in real time in the operating room. The systems have a multi-directional imaging arm which contains a near-infrared light source that illuminates the fluorescent agent within the tissues, a high definition (HD) video camera that captures the intensity of fluorescent marker in real-time, and software that allows the user to capture relative and absolute perfusion values within the surgical field. These products are FDA-approved for use to monitor blood flow, plastic surgery, microsurgery, reconstructive surgery, gastrointestinal imaging and coronary bypass surgery.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the same study drug.
| Arm | Type | Receives |
|---|---|---|
| Benign Bone patients | Experimental | Drug: Indocyanine GreenPatients with Benign Bone tumors requiring intralesional operative management will be administered immunofluorescent indocyanine green 24 hours prior to surgery, imaging of perfused tissues will be performed at the time of tumor removal. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects 12 years of age or older
- Diagnosis of any of the following that has been identified by imaging and/or biopsy:
- Intralesional operative management for their tumor planned
- Written informed consent signed by the subject if 18 years of age or older or by parent(s) or legally authorized representative if younger than 18 years of age. If younger than 18 years of age, the child must be able to be assent.
Key exclusion criteria (3 listed)
- Iodine allergy
- Women who are pregnant or breastfeeding
- Incarcerated individuals
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: ICGEnrolled subjects will receive Indocyanine Green administered the day prior to surgery during their standard-of-care preoperative appointment | Drug | Benign Bone patients |
Primary outcome
Fluorescent intensity contrast
Time frame: 24 hours post injection
fluorescence contrast suitable to facilitate fluorescence-guided surgical resection of benign bone tumors (tumor-to-background ratio > 2.0)
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 May 2024.
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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.
Eric R Henderson, MD principal investigator
Dartmouth-Hithcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Indocyanine Green in people with Bone Tumor, run by Dartmouth-Hitchcock Medical Center 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 16 inclusion and 3 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 May 2024. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Fluorescent intensity contrast (time frame: 24 hours post injection). 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 14 May 2024.