Recurrent MelanomaNCT01886235
Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery
A study testing Diagnostic Microscopy, Fluorescein Sodium Injection and Laboratory Biomarker Analysis in people with Recurrent Melanoma and Stage IA Skin Melanoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Melanoma, Stage IA Skin Melanoma, Stage IB 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2013to 6 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have measurable disease in their skin by direct visualization (visible lesion typically > 0.5 cm in maximal diameter); to perform a microscopic observation, the lesion will have to be visible by the naked eye, lined-up visually, and be able to interface with the microscope objective; a melanoma lesion that is smaller than 0.5 cm in diameter would present several obstacles to obtaining a reliable microscopic observation in the operating room; therefore, a visible lesion, at a minimum of 0.5 cm in diameter, is proposed for this study
- Melanoma tumor that requires a wide local excision in the operating room; this may include any stage of melanoma from stage IA to stage IV that requires a wide excision in the operating room
- Subject 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
- To determine any sensitivity to fluorescein, subject must have a skin prick test preoperatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given); a negative skin prick test to fluorescein is an inclusion criteria
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
- Melanoma deposit is deemed inaccessible to microscopic observation during the operative procedure (i.e., lesion is less than 0.5 cm or is not clearly visible to the naked eye)
- Renal dysfunction as defined as a glomerular filtration rate (GFR) < 70
- Any known allergy or prior reaction to fluorescein; also, a positive skin prick test to fluorescein is considered an exclusion criteria and the patient would not be eligible for entry into this study
- Pregnant or nursing female subjects
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiogram [EKG], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
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: A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients
This pilot clinical trial studies intravital microscopy for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of performing intravital microscopy on accessible human melanoma tumors during their standard course of treatment (i.e., wide local excision). (Part I)
SECONDARY OBJECTIVES:
- To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein (fluorescein sodium) as a marker of tumor vessel permeability. (Part II)
OUTLINE:
Patients receive fluorescein sodium intravenously (IV) followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
After completion of study treatment, patients are followed up at 3 weeks and then periodically for 5 years.
- Conditions
- Recurrent Melanoma, Stage IA Skin Melanoma, Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma
- Being tested
- Diagnostic Microscopy, Fluorescein Sodium Injection, Laboratory Biomarker Analysis, Therapeutic Conventional Surgery
- 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 Fluorescite
Given IV
Laboratory Biomarker AnalysisOther
Correlative studies
Therapeutic Conventional SurgeryProcedure or surgery
Undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis (intravital microscopy) | Experimental | Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma. Receives: Procedure: Diagnostic Microscopy; Drug: Fluorescein Sodium Injection; Other: Laboratory Biomarker Analysis; Procedure: Therapeutic Conventional Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision
A successful intravital microscopic observation will include the ability to identify tumor vessels, measure tumor vessel diameters, determine vessel density per 10 x field and visualize fluorescein within the tumor vessels.
Measured: Up to 2 months
Secondary outcomes (7)
"Percentage of Participants With Any Adverse Event
Percentage of participants with any adverse event. Described using upper one-sided 95% Clopper Pearson confidence limits.
Measured: Up to 5 years
Blood Flow Rates
Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.
Measured: Up to 2 months
Complication Rate
Number of participants with an event that would disrupt the standard surgical procedure or create an adverse event that would not be anticipated from the standard surgery.
Measured: Up to 5 years
Median Overall Survival
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Measured: Up to 5 years
Median Progression Free Survival
Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.
Measured: Up to 5 years
Percentage of Participants With Treatment Response
Treatment response was based upon the presence of a recurrence of the melanoma at either primary or metastatic sites.
Measured: Up to 5 years
Tumor Vasculature
Sample tumor characteristics obtained from the intervention will be characterized using descriptive statistics (mean, medians) and 95% confidence intervals.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study start4 Sep 2013
- Primary completion16 Jun 2015
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Joseph Skitzki, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886235
- Sponsor's protocol ID
- I 231512
- Other IDs
- NCI-2013-01052, I 231512, P30CA016056
- Status last verified
- Jul 2020
- First submitted
- 30 May 2013
- Last updated
- 7 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Feasibility of Performing Intravital Microscopy in Melanoma Patients
- ClinicalTrials.gov ID
- NCT01886235
- Acronym / sponsor ID
- I 231512
- Conditions
- Recurrent Melanoma, Stage IA Skin Melanoma, Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Sep 2013 (actual)
- Primary completion
- 16 Jun 2015 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Posted 6 Jun 2017
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 for identifying tumor vessels in patients with stage IA-IV melanoma that is being removed by surgery. New imaging procedures, such as intravital microscopy, may determine the extent of melanoma.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of performing intravital microscopy on accessible human melanoma tumors during their standard course of treatment (i.e., wide local excision). (Part I)
SECONDARY OBJECTIVES:
- To determine the blood flow velocity of the tumor vessels and tissue penetration of fluorescein (fluorescein sodium) as a marker of tumor vessel permeability. (Part II)
OUTLINE:
Patients receive fluorescein sodium intravenously (IV) followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.
After completion of study treatment, patients are followed up at 3 weeks and then periodically for 5 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis (intravital microscopy) | Experimental | Procedure: Diagnostic Microscopy, Drug: Fluorescein Sodium Injection, Other: Laboratory Biomarker Analysis, Procedure: Therapeutic Conventional SurgeryPatients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
- Have measurable disease in their skin by direct visualization (visible lesion typically > 0.5 cm in maximal diameter); to perform a microscopic observation, the lesion will have to be visible by the naked eye, lined-up visually, and be able to interface with the microscope objective; a melanoma lesion that is smaller than 0.5 cm in diameter would present several obstacles to obtaining a reliable microscopic observation in the operating room; therefore, a visible lesion, at a minimum of 0.5 cm in diameter, is proposed for this study
- Melanoma tumor that requires a wide local excision in the operating room; this may include any stage of melanoma from stage IA to stage IV that requires a wide excision in the operating room
- Subject 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
- To determine any sensitivity to fluorescein, subject must have a skin prick test preoperatively (at the time of the preoperative visit and after signed informed consent for entry into this clinical trial is given); a negative skin prick test to fluorescein is an inclusion criteria
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
- Melanoma deposit is deemed inaccessible to microscopic observation during the operative procedure (i.e., lesion is less than 0.5 cm or is not clearly visible to the naked eye)
- Renal dysfunction as defined as a glomerular filtration rate (GFR) < 70
- Any known allergy or prior reaction to fluorescein; also, a positive skin prick test to fluorescein is considered an exclusion criteria and the patient would not be eligible for entry into this study
- Pregnant or nursing female subjects
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 | Diagnosis (intravital microscopy) |
| Fluorescein Sodium InjectionAlso: FluoresciteGiven IV | Drug | Diagnosis (intravital microscopy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnosis (intravital microscopy) |
| Therapeutic Conventional SurgeryUndergo surgery | Procedure or surgery | Diagnosis (intravital microscopy) |
Primary outcome
Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision
Time frame: Up to 2 months
A successful intravital microscopic observation will include the ability to identify tumor vessels, measure tumor vessel diameters, determine vessel density per 10 x field and visualize fluorescein within the tumor vessels.
7 secondary outcomes
"Percentage of Participants With Any Adverse Event
Time frame: Up to 5 years
Blood Flow Rates
Time frame: Up to 2 months
Complication Rate
Time frame: Up to 5 years
Median Overall Survival
Time frame: Up to 5 years
Median Progression Free Survival
Time frame: Up to 5 years
Percentage of Participants With Treatment Response
Time frame: Up to 5 years
Tumor Vasculature
Time frame: Up to 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
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 Recurrent Melanoma and Stage IA 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 5 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 7 Aug 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?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Successful Intravital Microscopy on Accessible Human Melanoma Tumors During Standard Local Excision (time frame: Up to 2 months). 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 7 Aug 2020.