Endometrial CancerNCT02131558
Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer
A study testing ICG Dye in people with Endometrial Cancer and Sentinel Lymph Node Detection, run by Lahey Clinic at 1 site in United States.
Trial summary
Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be visualized using near-infrared (NIR) imagers. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Endometrial Cancer, Sentinel Lymph Node Detection
- What is being tested?
- ICG Dye
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 8 Mar 2017
- 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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women patients (>18 years of age and <90 years of age)
- Research authorization (consent)
- Pre-operative diagnosis of clinical Stage 1 endometrial cancer
- Pre-operative indications of grade 3 tumor, and/or tumor size greater than 2 cm in size
- Scheduled and consented to undergo robotic hysterectomy and surgical staging, including bilateral pelvic and para-aortic lymphadenectomy
Who cannot join
- Severe coagulopathy or severe thrombocytopenia
- Severe anemia
- Severe cardio-pulmonary comorbidities demanding minimization of operative time
- History of liver disease
- Iodide allergy
- Emergent operation
- Additional surgical risk as determined during surgery at the discretion of the attending
- Impaired capacity to make informed medical decisions
Trial locations and contacts
1 site in 1 country.
United States1 site
Lahey Hospital & Medical Center
Burlington, Massachusetts, 01805
About this study
Official title: The Feasibility and Benefits of Using Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer
Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG, sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will be identified. SLNs will be surgically removed and provided to Pathology for evaluation. Non-sentinel nodes will also be surgically removed, as is consistent with routine medical care for these patients, and given to Pathology for evaluation. A positive SLN may be the most accurate identifier of the extra-uterine spread of disease, and will provide information about the extent of surgical node removal necessary.
- Conditions
- Endometrial Cancer, Sentinel Lymph Node Detection
- Being tested
- ICG Dye
- Keywords
- Endometrial cancer, Sentinel lymph node, Indocyanine green, Near infrared imaging
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG DyeProcedure or surgery
ICG Dye injections
| Study group | Role | What they receive |
|---|---|---|
| ICG Dye | Experimental | Patients received injections of Indocyanine green (ICG) for sentinel lymph node (SLN) visualization using near-infrared (NIR) imaging. Receives: Procedure: ICG Dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of sentinel lymph node(s)
The primary outcome is to determine whether sentinel lymph nodes (SLN) were accurately visualized using Indocyanine green (ICG) and near-infrared (NIR) imaging.
Measured: Detection of SLNs will occur within surgery, on average this surgery will take "1-2 hours" for each participant
Secondary outcomes (1)
Comparison between sentinel node status for disease and non-sentinel node disease status
The pathological evaluation of the sentinel lymph nodes (positive or negative) will be compared to the status of the non-sentinel nodes removed to determine whether the sentinel nodes accurately reflected the same status as the non-sentinel nodes.
Measured: Following surgery and pathological evaluation of all removed nodes, up to "1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMay 2014
- Primary completion8 Mar 2017
- Study completion8 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahey Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valena Wright, Lahey Clinic
- Investigators
- Valena Wright, MD, Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131558
- Sponsor's protocol ID
- 2014-017
- Status last verified
- Aug 2020
- First submitted
- 7 Apr 2014
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Rossi EC, Jackson A, Ivanova A, Boggess JF. Detection of sentinel nodes for endometrial cancer with robotic assisted fluorescence imaging: cervical versus hysteroscopic injection. Int J Gynecol Cancer. 2013 Nov;23(9):1704-11. doi: 10.1097/IGC.0b013e3182a616f6.
PubMed 24177256Rossi EC, Ivanova A, Boggess JF. Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecol Oncol. 2012 Jan;124(1):78-82. doi: 10.1016/j.ygyno.2011.09.025. Epub 2011 Oct 11.
PubMed 21996262Abu-Rustum NR. Update on sentinel node mapping in uterine cancer: 10-year experience at Memorial Sloan-Kettering Cancer Center. J Obstet Gynaecol Res. 2014 Feb;40(2):327-34. doi: 10.1111/jog.12227.
PubMed 24620369Abu-Rustum NR. Sentinel lymph node mapping for endometrial cancer: a modern approach to surgical staging. J Natl Compr Canc Netw. 2014 Feb;12(2):288-97. doi: 10.6004/jnccn.2014.0026.
PubMed 24586087
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Benefits of Using Indocyanine Green and Near-infrared Fluorescence Imaging to Detect Sentinel Lymph Nodes in Patients With Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02131558
- Acronym / sponsor ID
- 2014-017
- Conditions
- Endometrial Cancer, Sentinel Lymph Node Detection
- Keywords
- Endometrial cancer, Sentinel lymph node, Indocyanine green, Near infrared imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Lahey ClinicUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 8 Mar 2017 (actual)
- First posted
- 6 May 2014 (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.
Patients with endometrial cancer who have planned robotic laparoscopic hysterectomy and full bilateral pelvic and para-aortic lymphadenectomy will receive injections of a fluorescent dye, Indocyanine green (ICG). ICG spreads through the lymphatic system, and will be visualized using near-infrared (NIR) imagers. Upon visualization of the path of the ICG, sentinel lymph nodes (SLNs), the first nodes to receive drainage from the primary tumor, will be identified. SLNs will be surgically removed and provided to Pathology for evaluation. Non-sentinel nodes will also be surgically removed, as is consistent with routine medical care for these patients, and given to Pathology for evaluation. A positive SLN may be the most accurate identifier of the extra-uterine spread of disease, and will provide information about the extent of surgical node removal necessary.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG Dye | Experimental | Procedure: ICG DyePatients received injections of Indocyanine green (ICG) for sentinel lymph node (SLN) visualization using near-infrared (NIR) imaging. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult women patients (>18 years of age and <90 years of age)
- Research authorization (consent)
- Pre-operative diagnosis of clinical Stage 1 endometrial cancer
- Pre-operative indications of grade 3 tumor, and/or tumor size greater than 2 cm in size
- Scheduled and consented to undergo robotic hysterectomy and surgical staging, including bilateral pelvic and para-aortic lymphadenectomy
Key exclusion criteria (8 listed)
- Severe coagulopathy or severe thrombocytopenia
- Severe anemia
- Severe cardio-pulmonary comorbidities demanding minimization of operative time
- History of liver disease
- Iodide allergy
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 |
|---|---|---|
| ICG DyeICG Dye injections | Procedure or surgery | ICG Dye |
Primary outcome
Detection of sentinel lymph node(s)
Time frame: Detection of SLNs will occur within surgery, on average this surgery will take "1-2 hours" for each participant
The primary outcome is to determine whether sentinel lymph nodes (SLN) were accurately visualized using Indocyanine green (ICG) and near-infrared (NIR) imaging.
1 secondary outcome
Comparison between sentinel node status for disease and non-sentinel node disease status
Time frame: Following surgery and pathological evaluation of all removed nodes, up to "1 year"
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 2 Sep 2020.
- Background: PubMed 24177256Rossi EC, Jackson A, Ivanova A, Boggess JF. Detection of sentinel nodes for endometrial cancer with robotic assisted fluorescence imaging: cervical versus hysteroscopic injection. Int J Gynecol Cancer. 2013 Nov;23(9):1704-11. doi: 10.1097/IGC.0b013e3182a616f6.
- Background: PubMed 21996262Rossi EC, Ivanova A, Boggess JF. Robotically assisted fluorescence-guided lymph node mapping with ICG for gynecologic malignancies: a feasibility study. Gynecol Oncol. 2012 Jan;124(1):78-82. doi: 10.1016/j.ygyno.2011.09.025. Epub 2011 Oct 11.
- Background: PubMed 24620369Abu-Rustum NR. Update on sentinel node mapping in uterine cancer: 10-year experience at Memorial Sloan-Kettering Cancer Center. J Obstet Gynaecol Res. 2014 Feb;40(2):327-34. doi: 10.1111/jog.12227.
- Background: PubMed 24586087Abu-Rustum NR. Sentinel lymph node mapping for endometrial cancer: a modern approach to surgical staging. J Natl Compr Canc Netw. 2014 Feb;12(2):288-97. doi: 10.6004/jnccn.2014.0026.
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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.
Valena Wright, MD principal investigator
Lahey Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG Dye in people with Endometrial Cancer and Sentinel Lymph Node Detection, run by Lahey Clinic 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 8 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 2 Sep 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?
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?
Detection of sentinel lymph node(s) (time frame: Detection of SLNs will occur within surgery, on average this surgery will take "1-2 hours" for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02131558, which also lists 4 linked publications.
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 2 Sep 2020.