Head and Neck CarcinomaPhase 1/2NCT03745690
Near-Infrared Image Guided Surgical Resection With Indocyanine Green in Treating Patients With Head and Neck Cancer
A Phase 1/2 study testing Image-Guided Surgery and Indocyanine Green Drug in people with Head and Neck Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This phase Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck cancer. Near-infrared image guided surgical resection with indocyanine green may make it easier to find and remove tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Image-Guided Surgery and Indocyanine Green Drug
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 8 Jun 2021
- Phase
- Phase 1/2
- 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
- Documentation of a head and neck cancer diagnosis as evidenced by tissue biopsy.
- Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
- Planned standard of care surgery with curative intent for squamous cell carcinoma.
- Have life expectancy of more than 12 weeks.
- Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1.
- Hemoglobin >= 9 gm/dL.
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- White blood cell count > 3000/mm^3.
- Platelet count >= 100,000/mm^3.
- Serum creatinine =< 1.5 mg/dL.
- Liver enzymes (aspartate aminotransferase [AST], alanine aminotransferase [ALT], and total bilirubin) =< 1.5 times the upper reference range.
- Written informed consent (and assent when applicable) obtained from subject or subject?s legal representative and ability for subject to comply with the requirements of the study.
- Agree to not have radioactive iodine uptake studies done within 1 week of indocyanine green.
Who cannot join
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Allergy to iodine or iodinated materials.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Phase 1B/2, Open-Label Study Evaluating Safety and Efficacy of Enhanced Permeability and Retention Effect for Near-Infrared Image Guided Surgical Resection of Head and Neck Cancers With Indocyanine Green
This phase Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck cancer. Near-infrared image guided surgical resection with indocyanine green may make it easier to find and remove tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the safety profile of high-dose optical dye, indocyanine green, in head and neck cancer surgical patients.
SECONDARY OBJECTIVES:
- Determine the efficacy of high-dose indocyanine green to identify cancer compared to surrounding normal tissue (tumor to background ratio; TBR) in head and neck cancer resections.
OUTLINE:
Patients receive indocyanine green intravenously (IV) on day 0 and undergo near-infrared image guided surgical resection on day 1.
After completion of study treatment, patients are followed up for 14-30 days.
- Conditions
- Head and Neck Carcinoma
- Being tested
- Image-Guided Surgery, Indocyanine Green Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Guided SurgeryProcedure or surgery
Undergo near-infrared image guided surgical resection
Indocyanine Green DrugDrug
Also called IC-GREEN, ICG Drug in solution
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (near-infrared image guided surgical resection) | Experimental | Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1. Receives: Procedure: Image-Guided Surgery; Drug: Indocyanine Green Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events
Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
Measured: Up to 30 days
Secondary outcomes (1)
Successful tumor fluorescence imaging data gathered for all patients included in the study
The effect of indocyanine green will be assessed by changes in tumor-to-background ratio (TBR). Tumor to background (TBR) data will be generated from still images collected throughout the procedure as previously described (Heath, Deep et al.). The presence of fluorescence in normal surrounding tissue will be correlated with fluorescence within the tumor mass. The linear relationship between fluorescence and tumor size will be computed as Spearman?s correlation coefficient. Continuous variable means (e.g., fluorescence intensity) will be compared to histological quantification of tumor as measured by the greatest dimension identified on the histopathological assessment.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start12 Dec 2018
- Primary completion8 Jun 2021 (estimated)
- Study completion8 Jun 2021 (estimated)
Why it stopped: no enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abie Mendelsohn, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745690
- Sponsor's protocol ID
- 18-000168
- Other IDs
- NCI-2018-02094, 18-000168
- Status last verified
- Mar 2022
- First submitted
- 15 Nov 2018
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1B/2, Open-Label Study Evaluating Safety and Efficacy of Enhanced Permeability and Retention Effect for Near-Infrared Image Guided Surgical Resection of Head and Neck Cancers With Indocyanine Green
- ClinicalTrials.gov ID
- NCT03745690
- Acronym / sponsor ID
- 18-000168
- Conditions
- Head and Neck Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 8 Jun 2021 (estimated)
- Study completion
- 8 Jun 2021 (estimated)
- First posted
- 19 Nov 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 Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck cancer. Near-infrared image guided surgical resection with indocyanine green may make it easier to find and remove tumors.
Detailed description
PRIMARY OBJECTIVES:
- To determine the safety profile of high-dose optical dye, indocyanine green, in head and neck cancer surgical patients.
SECONDARY OBJECTIVES:
- Determine the efficacy of high-dose indocyanine green to identify cancer compared to surrounding normal tissue (tumor to background ratio; TBR) in head and neck cancer resections.
OUTLINE:
Patients receive indocyanine green intravenously (IV) on day 0 and undergo near-infrared image guided surgical resection on day 1.
After completion of study treatment, patients are followed up for 14-30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (near-infrared image guided surgical resection) | Experimental | Procedure: Image-Guided Surgery, Drug: Indocyanine Green DrugPatients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Documentation of a head and neck cancer diagnosis as evidenced by tissue biopsy.
- Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
- Planned standard of care surgery with curative intent for squamous cell carcinoma.
- Have life expectancy of more than 12 weeks.
- Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1.
Key exclusion criteria (4 listed)
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- Allergy to iodine or iodinated materials.
- Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
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 |
|---|---|---|
| Image-Guided SurgeryUndergo near-infrared image guided surgical resection | Procedure or surgery | Treatment (near-infrared image guided surgical resection) |
| Indocyanine Green DrugAlso: IC-GREEN, ICG Drug in solutionGiven IV | Drug | Treatment (near-infrared image guided surgical resection) |
Primary outcome
Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events
Time frame: Up to 30 days
Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
1 secondary outcome
Successful tumor fluorescence imaging data gathered for all patients included in the study
Time frame: Up to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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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.
Abie Mendelsohn principal investigator
UCLA / Jonsson 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 Phase 1/2 study testing Image-Guided Surgery and Indocyanine Green Drug in people with Head and Neck Carcinoma, run by Jonsson 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 12 inclusion and 4 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: withdrawn, as of the sponsor's last update on 17 Mar 2022. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events (time frame: Up to 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 17 Mar 2022.