MelanomaPhase 1NCT01295931
Nuclear and Near-Infrared (NIR) Imaging in Melanoma
A Phase 1 study testing Indocyanine Green (IC-Green) and Imaging in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: 1. To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or inguinofemoral) 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Indocyanine Green (IC-Green) and Imaging
- 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
- Feb 2011to Oct 2014
- Phase
- Phase 1
- 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
- Subjects must be 18 years of age or older
- Diagnosis of invasive melanoma with (ARM A) biopsy documenting a T2 (greater than 1 mm thickness) primary tumor undergoing standard of care sentinel lymph node biopsy (SLN) for definitive pathologic staging, OR (ARM B) documented node-positive (stage III) disease undergoing standard-of-care axillary or inguinofemoral lymph node dissection for regional disease control.
- Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential.
- Female of childbearing potential who agrees to use a medically accepted method of contraception for a period of one (1) month following the study. Medically acceptable contraceptives include (i) hormonal contraceptives such as birth control pills, Depo-Provera, or Lupron Depot) if such is approved by the subject's Oncologist; (ii) barrier methods (such as a condom or diaphragm used with a spermicide, or (iii) an intrauterine device (IUD). Non-childbearing potential is defined as physiologically incapable of becoming pregnant, including any female who is post-menopausal; postmenopausal is defined as the time after which a woman has experienced 12 consecutive months of amenorrhea (lack of menstruation).
- For patients undergoing a complete axillary or inguinofemoral lymph node dissection a positive previous sentinel lymph node or a positive fine needle aspirate or core biopsy of their axillary or inguinofemoral lymph nodes.
Who cannot join
- Women who are pregnant or breast-feeding.
- Persons who are allergic to iodine
- A female of child-bearing potential who does not agree to use an approved contraceptive for one month after study participation.
- History of ipsilateral axillary or femoral surgery not including previous sentinel lymph node biopsy procedure.
- Persons who do not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Diagnostic Nodal Staging for Melanoma With Nuclear and Near-Infrared (NIR) Molecular Optical Imaging
Objectives:
- To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or inguinofemoral)
- To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic architecture and function by correlating the observed lymphatic structure and function with tumor and nodal status as determined from standard-of-care immunohistochemical evaluation.
Read the detailed description
Indocyanine Green Injections:
IC-Green Injections:
If you are found to be eligible to take part in this study, you will receive a total of 10-16 injections of IC-Green through a needle in your arms or legs, starting in your hands or feet (5-8 on each arm/leg), depending on the location of the tumor. You may receive additional injections in the torso, if there is a tumor in the torso area and the study doctor thinks it is needed. The study doctor will discuss the number of injections that you will receive in more detail. The injections will be given to you before surgery and all injections will be given intradermally (into or between layers of the skin).
The IC-Green injections will allow researchers to see how fluid flows through your body during imaging. This information may help future researchers more easily locate lymph nodes in patients scheduled for lymph node surgery.
After all of the IC-Green injections have been given, the imaging procedure will begin. To perform the imaging procedures, researchers will use an experimental camera that shines a special red light onto your skin causing the IC-Green to glow when the images are taken. The red light is like the red light in a grocery store scanner. The imaging procedure will take about 1 hour to complete and will be performed before and during the surgery.
Before the IC-Green injections and again during the imaging procedure, a member of the research staff will monitor and record your vital signs (blood pressure, breathing rate, heart rate, and temperature). Vital sign measurements will be taken every 15 minutes for 1 hour after the IC-Green injections, and every 30 minutes during the second hour. A study staff member will also closely monitor the injection site at these times for possible side effects. A study staff member will call you the next day and ask you to take your temperature. This phone call should last about 10 minutes.
Length of Study:
After all of the images have been taken, and the follow-up evaluation is complete, your participation in this study will be over.
Follow-Up Evaluation:
If you spend the night in the hospital after surgery, a study staff member will visit you in person the day after surgery. At this visit, your temperature will be recorded, you will be asked how you are feeling, and if you have experienced any side effects. The visit should last about 10 minutes.
If you do not spend the night in the hospital after surgery, you will be contacted by phone the day after the surgery and you will be asked what your current temperature is, how you are feeling, and if you have experienced any side effects. The phone call should last about 10 minutes.
This is an investigational study. IC-Green is FDA approved and commercially available for assessment of cardiac output, hepatic function, liver blood flow, ophthalmic angiography, and mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes in melanoma patients is investigational.
IC-Green is FDA approved to be injected into the vein. Giving IC-Green injections into or between layers of the skin and the device that is used to give the injections are investigational. The experimental camera, and the images taken with it, are being used for research purposes only and will not be used to manage your treatment.
Up to 18 patients will take part in Part 1 of this study. All will be enrolled at MD Anderson.
Complete Lymph Node Dissection:
If you agree to participate in this part of the study, you will have additional imaging performed before the surgery and again in your follow-up visit.
The imaging will be performed at MD Anderson just before the surgery and during your regularly scheduled standard of care follow-up visit about 4-6 months after surgery to learn what the lymphatic channels look like after completely healing from surgery.
Before each imaging session, you will receive a total of 10-16 injections of IC-Green through a needle in your arms and hands or legs and feet, (5-8 on each arm/leg), depending on the location of the tumor. Researchers will use the experimental camera to perform the imaging procedure. You may receive additional injections in the torso, if there is a tumor in the torso area and the study doctor thinks it is needed.
The imaging procedures will take up to 2 hours to complete each time.
For all participants, before the IC-Green injections and again during the imaging procedure, a member of the research staff will monitor and record your vital signs (blood pressure, breathing rate, heart rate, and temperature). Vital sign measurements will be taken every 15 minutes for 1 hour after the IC-Green injections, and every 30 minutes during the second hour. A study staff member will also closely monitor the injection site at these times for possible side effects.
Length of Study:
Your participation will be over after all the images have been taken and the long-term follow-up is complete.
This is an investigational study. IC-Green is FDA approved and commercially available for assessment of cardiac output, hepatic function, liver blood flow, ophthalmic angiography, and mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes in melanoma patients is investigational.
IC-Green is FDA approved to be injected into the vein. Giving IC-Green injections into or between layers of the skin and the device that is used to give the injections are investigational. The experimental camera, and the images taken with it, are being used for research purposes only and will not be used to manage your treatment.
Up to 6 patients will participate in this part of the study. All will be enrolled at MD Anderson.
- Conditions
- Melanoma
- Being tested
- Indocyanine Green (IC-Green), Imaging
- Keywords
- Near-infrared, NIR, Indocyanine green, ICG, Melanoma, Fluorescent dyes, Lymph nodes, Experimental camera
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (IC-Green)Drug
Also called ICG
5 intradermal injections, 25 µg IC-Green in 0.1 mL of saline, in locations on the extremity (i.e. arm or leg) correlating with the tumor draining nodal basin to begin. Corresponding injections performed on the contralateral limbs.
ImagingProcedure or surgery
Also called near-infrared, NIR, NIR fluorescence imaging
Nonradioactive optical imaging with indocyanine green as a fluorescent contrast agent prior to sentinel lymph node biopsy or lymph node surgery.
| Study group | Role | What they receive |
|---|---|---|
| IC-Green + Imaging | Experimental | Indocyanine Green (IC-Green) Injections + Imaging Receives: Drug: Indocyanine Green (IC-Green); Procedure: Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Nodes Identified by Indocyanine Green (ICG) Among All Resected Lymph Nodes
Procedure feasible if 18 out of 24 evaluable patients have 80% or more nodes identified by ICG among all resected nodes. Descriptive analyses performed to report the mean percentage and its 95% confidence interval of the nodes identified by ICG among the total resected nodes of all evaluable subjects. Outcome will be tabulated by age, different tumor stage, nodal status, and body mass index.
Measured: 18-24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Texas
- Responsible party
- Sponsor
- Investigators
- Janice N. Cormier, MD, MPH, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295931
- Sponsor's protocol ID
- 2010-0577
- Other IDs
- U54CA136404
- Status last verified
- Oct 2015
- First submitted
- 11 Feb 2011
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Nodal Staging for Melanoma With Nuclear and Near-Infrared (NIR) Molecular Optical Imaging
- ClinicalTrials.gov ID
- NCT01295931
- Acronym / sponsor ID
- 2010-0577
- Conditions
- Melanoma
- Keywords
- Near-infrared, NIR, Indocyanine green, ICG, Melanoma, Fluorescent dyes, Lymph nodes, Experimental camera
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Texas
- Study start
- Feb 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 15 Feb 2011 (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.
Objectives:
- To determine the feasibility of using microdose amounts of near-infrared (NIR) fluorescent contrast agent to image tumor-draining and contralateral lymphatics in melanoma patients prior to standard-of-care sentinel lymph node biopsy OR completion lymph node dissection (axillary or inguinofemoral)
- To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to characterize lymphatic architecture and function by correlating the observed lymphatic structure and function with tumor and nodal status as determined from standard-of-care immunohistochemical evaluation.
Detailed description
Indocyanine Green Injections:
IC-Green Injections:
If you are found to be eligible to take part in this study, you will receive a total of 10-16 injections of IC-Green through a needle in your arms or legs, starting in your hands or feet (5-8 on each arm/leg), depending on the location of the tumor. You may receive additional injections in the torso, if there is a tumor in the torso area and the study doctor thinks it is needed. The study doctor will discuss the number of injections that you will receive in more detail. The injections will be given to you before surgery and all injections will be given intradermally (into or between layers of the skin).
The IC-Green injections will allow researchers to see how fluid flows through your body during imaging. This information may help future researchers more easily locate lymph nodes in patients scheduled for lymph node surgery.
After all of the IC-Green injections have been given, the imaging procedure will begin. To perform the imaging procedures, researchers will use an experimental camera that shines a special red light onto your skin causing the IC-Green to glow when the images are taken. The red light is like the red light in a grocery store scanner. The imaging procedure will take about 1 hour to complete and will be performed before and during the surgery.
Before the IC-Green injections and again during the imaging procedure, a member of the research staff will monitor and record your vital signs (blood pressure, breathing rate, heart rate, and temperature). Vital sign measurements will be taken every 15 minutes for 1 hour after the IC-Green injections, and every 30 minutes during the second hour. A study staff member will also closely monitor the injection site at these times for possible side effects. A study staff member will call you the next day and ask you to take your temperature. This phone call should last about 10 minutes.
Length of Study:
After all of the images have been taken, and the follow-up evaluation is complete, your participation in this study will be over.
Follow-Up Evaluation:
If you spend the night in the hospital after surgery, a study staff member will visit you in person the day after surgery. At this visit, your temperature will be recorded, you will be asked how you are feeling, and if you have experienced any side effects. The visit should last about 10 minutes.
If you do not spend the night in the hospital after surgery, you will be contacted by phone the day after the surgery and you will be asked what your current temperature is, how you are feeling, and if you have experienced any side effects. The phone call should last about 10 minutes.
This is an investigational study. IC-Green is FDA approved and commercially available for assessment of cardiac output, hepatic function, liver blood flow, ophthalmic angiography, and mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes in melanoma patients is investigational.
IC-Green is FDA approved to be injected into the vein. Giving IC-Green injections into or between layers of the skin and the device that is used to give the injections are investigational. The experimental camera, and the images taken with it, are being used for research purposes only and will not be used to manage your treatment.
Up to 18 patients will take part in Part 1 of this study. All will be enrolled at MD Anderson.
Complete Lymph Node Dissection:
If you agree to participate in this part of the study, you will have additional imaging performed before the surgery and again in your follow-up visit.
The imaging will be performed at MD Anderson just before the surgery and during your regularly scheduled standard of care follow-up visit about 4-6 months after surgery to learn what the lymphatic channels look like after completely healing from surgery.
Before each imaging session, you will receive a total of 10-16 injections of IC-Green through a needle in your arms and hands or legs and feet, (5-8 on each arm/leg), depending on the location of the tumor. Researchers will use the experimental camera to perform the imaging procedure. You may receive additional injections in the torso, if there is a tumor in the torso area and the study doctor thinks it is needed.
The imaging procedures will take up to 2 hours to complete each time.
For all participants, before the IC-Green injections and again during the imaging procedure, a member of the research staff will monitor and record your vital signs (blood pressure, breathing rate, heart rate, and temperature). Vital sign measurements will be taken every 15 minutes for 1 hour after the IC-Green injections, and every 30 minutes during the second hour. A study staff member will also closely monitor the injection site at these times for possible side effects.
Length of Study:
Your participation will be over after all the images have been taken and the long-term follow-up is complete.
This is an investigational study. IC-Green is FDA approved and commercially available for assessment of cardiac output, hepatic function, liver blood flow, ophthalmic angiography, and mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes in melanoma patients is investigational.
IC-Green is FDA approved to be injected into the vein. Giving IC-Green injections into or between layers of the skin and the device that is used to give the injections are investigational. The experimental camera, and the images taken with it, are being used for research purposes only and will not be used to manage your treatment.
Up to 6 patients will participate in this part of the study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IC-Green + Imaging | Experimental | Drug: Indocyanine Green (IC-Green), Procedure: ImagingIndocyanine Green (IC-Green) Injections + Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects must be 18 years of age or older
- Diagnosis of invasive melanoma with (ARM A) biopsy documenting a T2 (greater than 1 mm thickness) primary tumor undergoing standard of care sentinel lymph node biopsy (SLN) for definitive pathologic staging, OR (ARM B) documented node-positive (stage III) disease undergoing standard-of-care axillary or inguinofemoral lymph node dissection for regional disease control.
- Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential.
- Female of childbearing potential who agrees to use a medically accepted method of contraception for a period of one (1) month following the study. Medically acceptable contraceptives include (i) hormonal contraceptives such as birth control pills, Depo-Provera, or Lupron Depot) if such is approved by the subject's Oncologist; (ii) barrier methods (such as a condom or diaphragm used with a spermicide, or (iii) an intrauterine device (IUD). Non-childbearing potential is defined as physiologically incapable of becoming pregnant, including any female who is post-menopausal; postmenopausal is defined as the time after which a woman has experienced 12 consecutive months of amenorrhea (lack of menstruation).
- For patients undergoing a complete axillary or inguinofemoral lymph node dissection a positive previous sentinel lymph node or a positive fine needle aspirate or core biopsy of their axillary or inguinofemoral lymph nodes.
Key exclusion criteria (5 listed)
- Women who are pregnant or breast-feeding.
- Persons who are allergic to iodine
- A female of child-bearing potential who does not agree to use an approved contraceptive for one month after study participation.
- History of ipsilateral axillary or femoral surgery not including previous sentinel lymph node biopsy procedure.
- Persons who do not meet inclusion criteria.
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 (IC-Green)Also: ICG5 intradermal injections, 25 µg IC-Green in 0.1 mL of saline, in locations on the extremity (i.e. arm or leg) correlating with the tumor draining nodal basin to begin. Corresponding injections performed on the contralateral limbs. | Drug | IC-Green + Imaging |
| ImagingAlso: near-infrared, NIR, NIR fluorescence imagingNonradioactive optical imaging with indocyanine green as a fluorescent contrast agent prior to sentinel lymph node biopsy or lymph node surgery. | Procedure or surgery | IC-Green + Imaging |
Primary outcome
Percentage of Nodes Identified by Indocyanine Green (ICG) Among All Resected Lymph Nodes
Time frame: 18-24 hours after procedure
Procedure feasible if 18 out of 24 evaluable patients have 80% or more nodes identified by ICG among all resected nodes. Descriptive analyses performed to report the mean percentage and its 95% confidence interval of the nodes identified by ICG among the total resected nodes of all evaluable subjects. Outcome will be tabulated by age, different tumor stage, nodal status, and body mass index.
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 7 Oct 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Janice N. Cormier, MD, MPH, BS principal investigator
M.D. Anderson 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 study testing Indocyanine Green (IC-Green) and Imaging in people with Melanoma, run by M.D. Anderson 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 5 inclusion and 5 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 Oct 2015. 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 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.
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 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?
Percentage of Nodes Identified by Indocyanine Green (ICG) Among All Resected Lymph Nodes (time frame: 18-24 hours after procedure). 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 Oct 2015.