Breast CancerPhase 1NCT01095913
Fluorescent Dyes for Lymph Node Mapping
A Phase 1 study testing Indocyanine green (ICG) in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this clinical research study is to find lymph nodes before surgery using a dye called indocyanine green (IC-Green). Objectives: 1. To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to identify all axillary lymph… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Indocyanine green (ICG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2010to Jan 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be 18 years of age or older
- Diagnosis of breast cancer requiring axillary nodal dissection
- Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential
- Females of childbearing potential who agree to use a medically accepted method of contraception for a period of one month following the study. Medically acceptable contraceptives include (i) hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot) if such use 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).
- Continuation of Inclusion #4: 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).
- Patients with a positive fine needle aspirate or core biopsy of their axillary 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 surgery including sentinel node biopsy
- Any patient who does not meet inclusion criteria for study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Health Science Center - Houston
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Near-Infrared Imaging of Fluorescent Dyes for Lymph Node Mapping
The goal of this clinical research study is to find lymph nodes before surgery using a dye called indocyanine green (IC-Green).
Objectives:
- To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to identify all axillary lymph nodes.
- To determine the feasibility of using nonradioactive optical imaging techniques with ICG as a fluorescent contrast agent to characterize lymphatic architecture and function in women with breast cancer who are scheduled for axillary node dissection.
Read the detailed description
IC-Green Injections:
If you are found to be eligible to take part in this study, a member of the study staff will give you between 6-16 injections of IC-Green through a needle in your hand, arm, and breast. The study doctor will discuss the number of injections that you will receive in more detail. The injections will be given after you are under anesthesia.
These IC-Green injections will allow researchers to see the flow of the liquid through your body during imaging and locate the lymph nodes that will be removed during your standard of care surgery. After all of the IC-Green injections have been given, the imaging procedure will begin. 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.
Before the IC-Green injections and during imaging, a member of the research staff will monitor and record your vital signs (blood pressure, breathing rate, heart rate, and temperature).
After the IC-Green injections, a study staff member will closely monitor the injection site for possible side effects every 15 minutes during the first hour, and then every 30 minutes during the second hour. A study staff member will call you the next day and ask you to take your temperature. This phone call should last about 5 minutes.
Follow-Up Evaluation:
If you spend the night in the hospital after your surgery, a study staff member will visit you for a follow-up the day after surgery. At this visit, your temperature will be recorded and you will be asked how you are feeling and if you have had 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 surgery. You will be asked the same questions described above, as well as what your temperature is. The 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.
This is an investigational study. IC-Green is FDA approved and commercially available for mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes in breast cancer patients is 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 20 patients will be take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Breast Cancer
- Being tested
- Indocyanine green (ICG)
- Keywords
- Near-Infrared Imaging, Fluorescent Dyes, Lymph Node Mapping, Indocyanine green, IC-Green, nonradioactive optical imaging, fluorescent contrast agent, ICG, lymph nodes, axillary nodal dissection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green (ICG)Drug
Also called IC-Green
Injections performed after induction of anesthesia for surgery; 25 µg ICG/injection, with injections of 0.1 cc each to be made starting in the hand, arm, and areolar regions of the breast.
| Study group | Role | What they receive |
|---|---|---|
| IC-Green Injections | Experimental | ICG Injections performed after induction of anesthesia for surgery; 25 µg ICG/injection, with injections of 0.1 cc each to be made starting in the hand, arm, and areolar regions of the breast. Receives: Drug: Indocyanine green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Nodes Identified by ICG Among All Resected Lymph Nodes for Each Patient
Measured: Injection and Imaging procedure takes 1+ hour to complete
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., National Cancer Institute (NCI), The University of Texas Health Science Center, Houston
- Responsible party
- Sponsor
- Investigators
- Funda Meric-Bernstam, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095913
- Sponsor's protocol ID
- 2009-0564
- Status last verified
- Jan 2015
- First submitted
- 26 Mar 2010
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Imaging of Fluorescent Dyes for Lymph Node Mapping
- ClinicalTrials.gov ID
- NCT01095913
- Acronym / sponsor ID
- 2009-0564
- Conditions
- Breast Cancer
- Keywords
- Near-Infrared Imaging, Fluorescent Dyes, Lymph Node Mapping, Indocyanine green, IC-Green, nonradioactive optical imaging, fluorescent contrast agent, ICG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., National Cancer Institute (NCI), The University of Texas Health Science Center, Houston
- Study start
- Mar 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Mar 2010 (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.
The goal of this clinical research study is to find lymph nodes before surgery using a dye called indocyanine green (IC-Green).
Objectives:
- To determine the feasibility of using nonradioactive optical imaging techniques with indocyanine green (ICG) as a fluorescent contrast agent to identify all axillary lymph nodes.
- To determine the feasibility of using nonradioactive optical imaging techniques with ICG as a fluorescent contrast agent to characterize lymphatic architecture and function in women with breast cancer who are scheduled for axillary node dissection.
Detailed description
IC-Green Injections:
If you are found to be eligible to take part in this study, a member of the study staff will give you between 6-16 injections of IC-Green through a needle in your hand, arm, and breast. The study doctor will discuss the number of injections that you will receive in more detail. The injections will be given after you are under anesthesia.
These IC-Green injections will allow researchers to see the flow of the liquid through your body during imaging and locate the lymph nodes that will be removed during your standard of care surgery. After all of the IC-Green injections have been given, the imaging procedure will begin. 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.
Before the IC-Green injections and during imaging, a member of the research staff will monitor and record your vital signs (blood pressure, breathing rate, heart rate, and temperature).
After the IC-Green injections, a study staff member will closely monitor the injection site for possible side effects every 15 minutes during the first hour, and then every 30 minutes during the second hour. A study staff member will call you the next day and ask you to take your temperature. This phone call should last about 5 minutes.
Follow-Up Evaluation:
If you spend the night in the hospital after your surgery, a study staff member will visit you for a follow-up the day after surgery. At this visit, your temperature will be recorded and you will be asked how you are feeling and if you have had 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 surgery. You will be asked the same questions described above, as well as what your temperature is. The 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.
This is an investigational study. IC-Green is FDA approved and commercially available for mapping heart, liver, and eye function. The use of IC-Green for mapping the lymph nodes in breast cancer patients is 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 20 patients will be take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IC-Green Injections | Experimental | Drug: Indocyanine green (ICG)ICG Injections performed after induction of anesthesia for surgery; 25 µg ICG/injection, with injections of 0.1 cc each to be made starting in the hand, arm, and areolar regions of the breast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must be 18 years of age or older
- Diagnosis of breast cancer requiring axillary nodal dissection
- Negative urine pregnancy test within 72 hours prior to study drug administration, if female of childbearing potential
- Females of childbearing potential who agree to use a medically accepted method of contraception for a period of one month following the study. Medically acceptable contraceptives include (i) hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot) if such use 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).
- Continuation of Inclusion #4: 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).
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 surgery including sentinel node biopsy
- Any patient who does not meet inclusion criteria for study
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 (ICG)Also: IC-GreenInjections performed after induction of anesthesia for surgery; 25 µg ICG/injection, with injections of 0.1 cc each to be made starting in the hand, arm, and areolar regions of the breast. | Drug | IC-Green Injections |
Primary outcome
Percentage of Nodes Identified by ICG Among All Resected Lymph Nodes for Each Patient
Time frame: Injection and Imaging procedure takes 1+ hour to complete
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 8 Jan 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.
Funda Meric-Bernstam, MD study chair
M.D. Anderson Cancer Center
2 sites 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 (ICG) in people with Breast Cancer, run by M.D. Anderson Cancer Center at 2 sites 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 6 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 8 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 ICG Among All Resected Lymph Nodes for Each Patient (time frame: Injection and Imaging procedure takes 1+ hour to complete). 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 8 Jan 2015.