Neck DissectionNCT03532581
Indocyanine Green Lymphangiography in Identifying Thoracic Duct During Neck Surgery
A study testing Indocyanine Green Solution and Lymphangiography in people with Neck Dissection and Radical Lymph Node Dissection, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase I trial studies how well indocyanine green lymphangiography works in identifying thoracic duct during neck surgery. Diagnostic procedures, such as near infrared fluorescence imaging with indocyanine green may help recognize and prevent injury to thoracic duct during neck surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Dissection, Radical Lymph Node Dissection
- What is being tested?
- Indocyanine Green Solution and Lymphangiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 7 Mar 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult patients who are undergoing LEFT modified radical or selective (including zone IV) lymph node dissection for any indication; this includes patients who have had prior neck surgery
Who cannot join
- Children, minors, pregnant women, women who are breast feeding, institutionalized patients
- Known prior allergic reaction to ICG or allergy to iodine
- Patients with excessively high anesthesia risks who cannot tolerate the extra time under general anesthesia needed to perform this study; the surgeon and anesthesiologist will determine this pre-operatively
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: A Novel Surgical Technique: Indocyanine Green Lymphangiography for Identification of the Thoracic Duct During Neck Dissection
This phase I trial studies how well indocyanine green lymphangiography works in identifying thoracic duct during neck surgery. Diagnostic procedures, such as near infrared fluorescence imaging with indocyanine green may help recognize and prevent injury to thoracic duct during neck surgery.
Read the detailed description
PRIMARY OBJECTIVES:
- Feasibility and optimization of thoracic duct identification using indocyanine green (ICG) lymphangiography.
II. To explore specifically how identifying the thoracic duct (TD) will prevent injury intra-operatively.
III. To understand if a TD injury can be recognized by leakage of fluorescent chyle into the operating field.
OUTLINE:
Participants receive indocyanine green solution subcutaneously (SC) and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.
After completion of study treatment, participants are followed up for up to 1 year.
- Conditions
- Neck Dissection, Radical Lymph Node Dissection
- Being tested
- Indocyanine Green Solution, Lymphangiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green SolutionOther
Also called IC-GREEN, ICG Solution
Given Subcutaneous injection
LymphangiographyProcedure or surgery
Also called Lymphography
Undergo lymphangiography
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ICG lymphangiography) | Experimental | Participants receive indocyanine green solution SC and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery. Receives: Other: Indocyanine Green Solution; Procedure: Lymphangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify thoracic duct (TD) using indocyanine green (ICG)
We will determine in how many patients the thoracic duct is identified by white light visualization and by ICG fluorescence. The collected data will be primarily qualitative as determined by the surgeon.
Measured: Up to 1 year
Prevent injury to the TD
Percentage of patients with TD injury will be calculated and compared to contemporary rates of injury.
Measured: Up to 1 year
Recognize injury intra-operatively
Will be mostly qualitative data collection on how the injury was identified and in what percent.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start23 Apr 2018
- Primary completion7 Mar 2023
- Study completion7 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck DissectionStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Phay, MD, Ohio State University Comprehensive Cancer Center
- Investigators
- John Phay, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532581
- Sponsor's protocol ID
- OSU-17368
- Other IDs
- NCI-2018-00390
- Status last verified
- Jan 2024
- First submitted
- 19 Apr 2018
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Surgical Technique: Indocyanine Green Lymphangiography for Identification of the Thoracic Duct During Neck Dissection
- ClinicalTrials.gov ID
- NCT03532581
- Acronym / sponsor ID
- OSU-17368
- Conditions
- Neck Dissection, Radical Lymph Node Dissection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 7 Mar 2023 (actual)
- First posted
- 22 May 2018 (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 phase I trial studies how well indocyanine green lymphangiography works in identifying thoracic duct during neck surgery. Diagnostic procedures, such as near infrared fluorescence imaging with indocyanine green may help recognize and prevent injury to thoracic duct during neck surgery.
Detailed description
PRIMARY OBJECTIVES:
- Feasibility and optimization of thoracic duct identification using indocyanine green (ICG) lymphangiography.
II. To explore specifically how identifying the thoracic duct (TD) will prevent injury intra-operatively.
III. To understand if a TD injury can be recognized by leakage of fluorescent chyle into the operating field.
OUTLINE:
Participants receive indocyanine green solution subcutaneously (SC) and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery.
After completion of study treatment, participants are followed up for up to 1 year.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ICG lymphangiography) | Experimental | Other: Indocyanine Green Solution, Procedure: LymphangiographyParticipants receive indocyanine green solution SC and undergo near-infrared imaging over 1-2 minutes during their standard of care neck surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult patients who are undergoing LEFT modified radical or selective (including zone IV) lymph node dissection for any indication; this includes patients who have had prior neck surgery
Key exclusion criteria (3 listed)
- Children, minors, pregnant women, women who are breast feeding, institutionalized patients
- Known prior allergic reaction to ICG or allergy to iodine
- Patients with excessively high anesthesia risks who cannot tolerate the extra time under general anesthesia needed to perform this study; the surgeon and anesthesiologist will determine this pre-operatively
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 SolutionAlso: IC-GREEN, ICG SolutionGiven Subcutaneous injection | Other | Treatment (ICG lymphangiography) |
| LymphangiographyAlso: LymphographyUndergo lymphangiography | Procedure or surgery | Treatment (ICG lymphangiography) |
Primary outcome
Identify thoracic duct (TD) using indocyanine green (ICG)
Time frame: Up to 1 year
We will determine in how many patients the thoracic duct is identified by white light visualization and by ICG fluorescence. The collected data will be primarily qualitative as determined by the surgeon.
Prevent injury to the TD
Time frame: Up to 1 year
Percentage of patients with TD injury will be calculated and compared to contemporary rates of injury.
Recognize injury intra-operatively
Time frame: Up to 1 year
Will be mostly qualitative data collection on how the injury was identified and in what percent.
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 16 Jan 2024.
- The JameslineLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
John Phay, MD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green Solution and Lymphangiography in people with Neck Dissection and Radical Lymph Node Dissection, run by Ohio State University Comprehensive Cancer 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 1 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 16 Jan 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.
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?
Identify thoracic duct (TD) using indocyanine green (ICG) (time frame: Up to 1 year). The study lists 3 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 16 Jan 2024.