Stage IB Skin MelanomaNCT02857374
Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy
A study testing Diagnostic Microscopy, Fluorescein Sodium Injection and Laboratory Biomarker Analysis in people with Stage IB Skin Melanoma and Stage IIA Skin Melanoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This pilot clinical trial studies intravital microscopy in identifying tumor vessels in patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn specific information regarding how melanoma may… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma
- What is being tested?
- Diagnostic Microscopy, Fluorescein Sodium Injection and Laboratory Biomarker Analysis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2016to 13 Jun 2022
- 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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Melanoma tumor that meets indications for a groin SLN biopsy with a >= 10% risk of having metastasis to the draining lymph node (i.e. stage IB to stage IIIC melanoma of the lower body below the umbilicus)
- Participant must be eligible for a groin sentinel lymph node (SLN) biopsy
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Sentinel lymph node is deemed inaccessible to microscopic observation during the operative procedure (i.e. sentinel node maps to a deep location or area outside of the groin)
- Renal dysfunction as defined as creatinine clearance < 70 mL/min by Cockroft-Gault equation
- Any known allergy or prior reaction to fluorescein, indocyanine green, iodine, or shellfish
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests)
- Any condition that excludes SLN biopsy as the standard of care (e.g. lymphadenectomy indicated)
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Intravital Microscopy (IVM) During Sentinel Lymph Node (SLN) Biopsy for Melanoma
This pilot clinical trial studies intravital microscopy in identifying tumor vessels in patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn specific information regarding how melanoma may spread to lymph nodes and other sites of the body.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of intravital microscopy in characterizing the microvasculature of the sentinel lymph node (SLN) in melanoma patients requiring SLN biopsy.
SECONDARY OBJECTIVES:
- To identify vascular blood flow parameters and flow kinetics associated with the sentinel lymph node vasculature and define the utility of using commonly used fluorescent agents during human intravital microscopy and correlate with clinical outcomes (time to recurrence, survival), as a potential basis for a novel prognostic tool and/or microstaging technique.
TERTIARY OBJECTIVES:
- To determine the relationship between live microscopically-recorded images and pathology slides in terms of vessel density and vessel diameter.
OUTLINE:
Patients receive indocyanine green and fluorescein sodium injection intravenously (IV) and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.
After completion of study treatment, patients are followed up at 3 weeks and then every 6 months for 5 years or every 3 months for 2 years and every 6 months for another 2 years.
- Conditions
- Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma
- Being tested
- Diagnostic Microscopy, Fluorescein Sodium Injection, Laboratory Biomarker Analysis, Sentinel Lymph Node Biopsy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic MicroscopyProcedure or surgery
Undergo intravital microscopy
Fluorescein Sodium InjectionDrug
Also called AK-Fluor, Fluorescite
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Sentinel Lymph Node BiopsyProcedure or surgery
Also called Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB
Undergo standard of care sentinel node biopsy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (intravital microscopy) | Experimental | Patients receive indocyanine green and fluorescein sodium injection IV and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy. Receives: Procedure: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection; Other: Laboratory Biomarker Analysis; Procedure: Sentinel Lymph Node Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intravital microscopy in characterizing the microvasculature of the SLN in melanoma determined by successful visualization of at least 6 of 10 patients during Part I
The visualization method will be deemed successful in patients with tumor vessel identification, measurement of tumor vessel diameters, determining vessel density, and visualizing fluorescein/indocyanine green within the tumor vessels.
Measured: Up to 3 weeks
Secondary outcomes (6)
Flow kinetics associated with the sentinel lymph node vasculature
Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.
Measured: Up to 5 years
Survival
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Measured: Up to 5 years
Time to progression
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Measured: Up to 5 years
Treatment response
Assessed using Logistic Regression. Collected through routine follow-up processes.
Measured: Up to 5 years
Utility of using commonly used fluorescent agents during human intravital microscopy
Measured: Up to 3 weeks
Vascular blood flow parameters associated with the sentinel lymph node vasculature
Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start3 Nov 2016
- Primary completion28 Aug 2018
- Study completion13 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IB Skin MelanomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Skitzki, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857374
- Sponsor's protocol ID
- I 284116
- Other IDs
- NCI-2016-01076, I 284116
- Status last verified
- Jul 2022
- First submitted
- 29 Jul 2016
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravital Microscopy (IVM) During Sentinel Lymph Node (SLN) Biopsy for Melanoma
- ClinicalTrials.gov ID
- NCT02857374
- Acronym / sponsor ID
- I 284116
- Conditions
- Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 5 Aug 2016 (estimated)
- 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 pilot clinical trial studies intravital microscopy in identifying tumor vessels in patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn specific information regarding how melanoma may spread to lymph nodes and other sites of the body.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of intravital microscopy in characterizing the microvasculature of the sentinel lymph node (SLN) in melanoma patients requiring SLN biopsy.
SECONDARY OBJECTIVES:
- To identify vascular blood flow parameters and flow kinetics associated with the sentinel lymph node vasculature and define the utility of using commonly used fluorescent agents during human intravital microscopy and correlate with clinical outcomes (time to recurrence, survival), as a potential basis for a novel prognostic tool and/or microstaging technique.
TERTIARY OBJECTIVES:
- To determine the relationship between live microscopically-recorded images and pathology slides in terms of vessel density and vessel diameter.
OUTLINE:
Patients receive indocyanine green and fluorescein sodium injection intravenously (IV) and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.
After completion of study treatment, patients are followed up at 3 weeks and then every 6 months for 5 years or every 3 months for 2 years and every 6 months for another 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (intravital microscopy) | Experimental | Procedure: Diagnostic Microscopy, Drug: Fluorescein Sodium Injection, Other: Laboratory Biomarker Analysis, Procedure: Sentinel Lymph Node BiopsyPatients receive indocyanine green and fluorescein sodium injection IV and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Melanoma tumor that meets indications for a groin SLN biopsy with a >= 10% risk of having metastasis to the draining lymph node (i.e. stage IB to stage IIIC melanoma of the lower body below the umbilicus)
- Participant must be eligible for a groin sentinel lymph node (SLN) biopsy
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Key exclusion criteria (7 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Sentinel lymph node is deemed inaccessible to microscopic observation during the operative procedure (i.e. sentinel node maps to a deep location or area outside of the groin)
- Renal dysfunction as defined as creatinine clearance < 70 mL/min by Cockroft-Gault equation
- Any known allergy or prior reaction to fluorescein, indocyanine green, iodine, or shellfish
- Unwilling or unable to follow protocol requirements
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 |
|---|---|---|
| Diagnostic MicroscopyUndergo intravital microscopy | Procedure or surgery | Diagnostic (intravital microscopy) |
| Fluorescein Sodium InjectionAlso: AK-Fluor, FluoresciteGiven IV | Drug | Diagnostic (intravital microscopy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (intravital microscopy) |
| Sentinel Lymph Node BiopsyAlso: Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNBUndergo standard of care sentinel node biopsy | Procedure or surgery | Diagnostic (intravital microscopy) |
Primary outcome
Feasibility of intravital microscopy in characterizing the microvasculature of the SLN in melanoma determined by successful visualization of at least 6 of 10 patients during Part I
Time frame: Up to 3 weeks
The visualization method will be deemed successful in patients with tumor vessel identification, measurement of tumor vessel diameters, determining vessel density, and visualizing fluorescein/indocyanine green within the tumor vessels.
6 secondary outcomes
Flow kinetics associated with the sentinel lymph node vasculature
Time frame: Up to 5 years
Survival
Time frame: Up to 5 years
Time to progression
Time frame: Up to 5 years
Treatment response
Time frame: Up to 5 years
Utility of using commonly used fluorescent agents during human intravital microscopy
Time frame: Up to 3 weeks
Vascular blood flow parameters associated with the sentinel lymph node vasculature
Time frame: Up to 5 years
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 1 Aug 2022.
Related trials for Stage IB Skin Melanoma
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced or Metastatic Solid Tumors, NSCLC
RecruitingPhase 1/2
A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
Melanoma, Solid Tumors
Active, not recruitingPhase 1
Study of Safety and Efficacy of DKY709 Alone or in Combination With PDR001 in Patients With Advanced Solid Tumors.
Carcinoma, Non-Small-Cell Lung, Melanoma
RecruitingPhase 1
Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA)
Melanoma (Skin Cancer), Breast Cancer
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.
Joseph Skitzki principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Microscopy, Fluorescein Sodium Injection and Laboratory Biomarker Analysis in people with Stage IB Skin Melanoma and Stage IIA Skin Melanoma, run by Roswell Park Cancer Institute 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 4 inclusion and 7 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 1 Aug 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.
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?
Feasibility of intravital microscopy in characterizing the microvasculature of the SLN in melanoma determined by successful visualization of at least 6 of 10 patients during Part I (time frame: Up to 3 weeks). 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 1 Aug 2022.