Head and Neck CancerNCT03297957
Fluorescence Imaging in Head and Neck Cancer
A study testing Hands-free goggle system in people with Head and Neck Cancer and Cancer of the Head and Neck, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Cancer of the Head and Neck
- What is being tested?
- Hands-free goggle system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2017to 15 Apr 2019
- 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
- Adults aged 18 years or older will be considered eligible.
- Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma. Patients with central neck pathology including thyroid neoplasms, parathyroid neoplasms, and laryngeal neoplasms undergoing surgical resection.
- Candidates for sentinel lymph node biopsy or central neck surgery
- Newly diagnosed with clinically node negative head and neck cancer being staged with sentinel lymph node biopsy.
- Not pregnant or breast feeding.
- Able to understand and willing to sign an IRB-approved written informed consent document.
- Able to understand written or spoken English.
Who cannot join
- History of allergy to iodide drugs or shellfish (iodine allergy)
- Pregnant or breast feeding
- Do not fit age criteria
- Prisoners
- Unable to provide written consent
- Contraindications for surgery
- Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection of the head and neck, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Receiving any other investigational agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Evaluation of Fluorescence Imaging in Head and Neck Cancer
Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no system has been studied specifically for head and neck sentinel lymph node biopsies using a hands free goggle system that can visualize white light (normal surgical visualization) and nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of time required to perform the SLNB procedure.
Regarding parathyroid identification, this technology has the potential to identify these very small glands during procedures they are at risk. These glands are not only at risk of inadvertent removal if not adequately identified, but may also be at risk if devascularized by manipulation during the surgical procedure. Therefore, early and accurate identification may decrease the rate of temporary and permanent hypoparathyroidism and hypocalcemia. This is not only an issue during thyroid and parathyroid surgery, but during laryngectomy surgery where the anatomic region these glands are located are often resected to remove at risk lymph nodes from cancer spread. Therefore, identifying these glands may help preserve parathyroid function in this patient population as well.
- Conditions
- Head and Neck Cancer, Cancer of the Head and Neck
- Being tested
- Hands-free goggle system
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hands-free goggle systemDevice
-Manufactured at Washington University
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Goggle Imaging | Experimental | -Patient will then be taken to the operating room for this surgical procedure. Prior to starting the operation, the patient will undergo injection of ICG around the tumor per standard techniques while in the operating room. Those undergoing intraoperative visualization of parathyroid glands will not have any administration of ICG as these glands autofluoresce. Patients will then undergo the standard SLN biopsy procedure (those undergoing parathyroid visualization will not undergo this). The surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance or parathryroid visualization. After this is performed, the goggle system will be removed and the procedure will be completed per normal. Receives: Device: Hands-free goggle system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
-Feasibility will be assessed in terms of percentage of patients enrolled for whom peri-tumoral injection with ICG is performed successfully
Measured: Up to 1 week after surgery
Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
-Feasibility will be assessed in terms of percentage patients whom the sentinel and superficial lymph nodes will be detected from the hands free goggle device
Measured: Up to 1 week after surgery
Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
-Feasibility will be assessed in terms of percentage of total lesions identified from the new technique are truly positive as confirmed by biopsy
Measured: Up to 1 week after surgery
Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
-Feasibility will be assessed in terms of the the percentage of total positive SNLs being missed from the new device
Measured: Up to 1 week after surgery
Ability of the hands-free goggle system to identify parathryoid glands during central neck surgeries
Measured: Up to 1 week after surgery
Secondary outcomes (1)
Determine if there is contrast between SLN and surrounding tissues using the novel fluorescence imaging device
Measured: Up to 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start14 Sep 2017
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ryan S Jackson, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297957
- Sponsor's protocol ID
- 201708068
- Status last verified
- Jan 2020
- First submitted
- 26 Sep 2017
- Last updated
- 18 Jan 2020
- 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 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluorescence Imaging in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT03297957
- Acronym / sponsor ID
- 201708068
- Conditions
- Head and Neck Cancer, Cancer of the Head and Neck
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 29 Sep 2017 (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.
Fluorescent technology continues to advance in the detection of sentinel lymph nodes (SLNs). Currently, this requires switching from near-infrared light to white light to be able to identify the fluorescent tissue contrasting with normal surrounding tissue. Currently, no system has been studied specifically for head and neck sentinel lymph node biopsies using a hands free goggle system that can visualize white light (normal surgical visualization) and nearinfrared light (ICG fluorescence) simultaneously. This technology may have implications on the safety and accuracy of sentinel lymph node biopsy for head and neck mucosal and cutaneous tumors. Secondarily, this may reduce operative costs by decreasing the amount of time required to perform the SLNB procedure.
Regarding parathyroid identification, this technology has the potential to identify these very small glands during procedures they are at risk. These glands are not only at risk of inadvertent removal if not adequately identified, but may also be at risk if devascularized by manipulation during the surgical procedure. Therefore, early and accurate identification may decrease the rate of temporary and permanent hypoparathyroidism and hypocalcemia. This is not only an issue during thyroid and parathyroid surgery, but during laryngectomy surgery where the anatomic region these glands are located are often resected to remove at risk lymph nodes from cancer spread. Therefore, identifying these glands may help preserve parathyroid function in this patient population as well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Goggle Imaging | Experimental | Device: Hands-free goggle system-Patient will then be taken to the operating room for this surgical procedure. Prior to starting the operation, the patient will undergo injection of ICG around the tumor per standard techniques while in the operating room. Those undergoing intraoperative visualization of parathyroid glands will not have any administration of ICG as these glands autofluoresce. Patients will then undergo the standard SLN biopsy procedure (those undergoing parathyroid visualization will not undergo this). The surgeon will put on the goggle system to attempt to identify the SLN using fluorescence guidance or parathryroid visualization. After this is performed, the goggle system will be removed and the procedure will be completed per normal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 18 years or older will be considered eligible.
- Patients with head and neck malignancies, such as melanoma, non-melanoma cutaneous malignancies, or oral cavity squamous cell carcinoma. Patients with central neck pathology including thyroid neoplasms, parathyroid neoplasms, and laryngeal neoplasms undergoing surgical resection.
- Not pregnant or breast feeding.
- Able to understand and willing to sign an IRB-approved written informed consent document.
- Able to understand written or spoken English.
Key exclusion criteria (8 listed)
- History of allergy to iodide drugs or shellfish (iodine allergy)
- Pregnant or breast feeding
- Do not fit age criteria
- Prisoners
- Unable to provide written consent
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 |
|---|---|---|
| Hands-free goggle system-Manufactured at Washington University | Device | Arm 1: Goggle Imaging |
Primary outcome
Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
Time frame: Up to 1 week after surgery
-Feasibility will be assessed in terms of percentage of patients enrolled for whom peri-tumoral injection with ICG is performed successfully
Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
Time frame: Up to 1 week after surgery
-Feasibility will be assessed in terms of percentage patients whom the sentinel and superficial lymph nodes will be detected from the hands free goggle device
Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
Time frame: Up to 1 week after surgery
-Feasibility will be assessed in terms of percentage of total lesions identified from the new technique are truly positive as confirmed by biopsy
Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure
Time frame: Up to 1 week after surgery
-Feasibility will be assessed in terms of the the percentage of total positive SNLs being missed from the new device
Ability of the hands-free goggle system to identify parathryoid glands during central neck surgeries
Time frame: Up to 1 week after surgery
1 secondary outcome
Determine if there is contrast between SLN and surrounding tissues using the novel fluorescence imaging device
Time frame: Up to 1 week after surgery
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Ryan S Jackson, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hands-free goggle system in people with Head and Neck Cancer and Cancer of the Head and Neck, run by Washington University School of Medicine 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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Jan 2020. 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 was stopped early (reason given: Low accrual). Results are not available in the source record.
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?
Feasibility of using a novel fluorescence imaging device to detect a SLN as measured by the ability of the imaging device to identity the SLN by the surgeon during the standard biopsy procedure (time frame: Up to 1 week after surgery). The study lists 5 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 18 Jan 2020.