Endometrial CancerPhase 2NCT00671606
Hysteroscopic Lymphatic Mapping for Endometrial Cancer
A Phase 2 study testing Intraoperative Lymphatic Mapping in people with Endometrial 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 learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Intraoperative Lymphatic Mapping
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Jun 2010
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with biopsy confirmed endometrial cancer who have been dispositioned to undergo total hysterectomy, bilateral salpingooophorectomy and lymph node staging.
- Surgical procedures may be performed by either laparotomy or laparoscopy.
- If computed tomography, magnetic resonance imaging, lymphangiography, or ultrasound has been performed for preoperative assessment, there must be no evidence of metastases. Imaging is not mandatory.
- Patients who have signed an approved informed consent and authorization permitting release of personal health information.
Who cannot join
- Patients with a preoperative diagnosis of grade I endometrioid adenocarcinoma of the uterus.
- Patients with uterine papillary serous carcinoma.
- Patients who have undergone endometrial ablation or a myomectomy within 1 year of the surgery for endometrial cancer.
- Patients with known allergies to triphenylmethane compounds or technetium-99 radiocolloid.
- Patients with a history of retroperitoneal surgery.
- Patients with a history of pelvic radiation.
- Patients with no lesion visible on hysteroscopy.
- Patients with previous exposure to the tracer (to prevent risk of allergic reaction).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Luke's Episcopal Hospital
Houston, Texas, 77030
UT MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer
The goal of this clinical research study is to learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer.
Read the detailed description
Experimental Procedures:
Lymph nodes are oval-shaped glands where immune reactions occur. For patients with endometrial cancer, lymph node status is an important factor for planning the cancer treatment course and predicting the status of the cancer. The "sentinel" node is the lymph node closest to the main tumor area, and it is believed to be at greatest risk for spread of the cancer. If the sentinel node does not contain cancer cells, then the remaining lymph nodes are usually cancer-free.
In this study, researchers want to study possibly using lymphatic mapping in future patients as an alternative to completely removing the lymph nodes in the pelvis (hip area) and para-aortic (upper abdomen) area.
Intraoperative sentinel lymph node identification (lymphatic mapping) uses 2 techniques. The first technique involves injecting a small amount of weak radioactive material, and the second involves injecting a drug called isosulfan blue or methylene blue. These techniques are being studied to see if the surgeon can locate ("map") lymph nodes that may contain tumor cells.
Routine Surgical Treatment:
As part of routine care, all participants in this study will have surgery to remove the uterus, cervix, 1-2 inches of the vagina, fallopian tubes, ovaries, and the lymph nodes in 2 areas of the waist.
Study Procedures:
If you agree to take part in this study, after you have been given the anesthetic for your surgery, your uterus will be examined to locate the tumor(s). After the tumor(s) are located, they will be injected with a radioactive substance called Tc-99m sulfur colloid. The tumors will then be injected with a dye called isosulfan blue or methylene blue, which is used to turn the sentinel node blue.
Before and during your surgery, a gamma counter (a special hand-held instrument that measures radioactivity) will be used to identify lymph nodes that have absorbed the Tc-99m sulfur colloid. The surgeon will also be able to see the lymph nodes that have absorbed the blue dye.
Information Collection:
In addition to the study procedures, researchers will collect clinical information about you that will be compared with the study results. This information includes your date of birth, age, race, height, weight, number of any past pregnancies and deliveries, any other medical conditions, and any earlier surgeries. It also includes the date of the cancer diagnosis, the status of the cancer diagnosis before surgery, the status of the disease, and the results of routine scans before surgery (chest x-ray and computed tomography [CT] or magnetic resonance imaging [MRI] scan, if performed).
Length of Study Participation:
Your participation in this study will be over after the 15-20 minute procedure for identifying the sentinel nodes. The routine surgery will occur after that, which can take up to 5 hours.
This is an investigational study. Tc-99m sulfur colloid, the blue dye (either isosulfan blue or methylene blue), and the gamma counter are FDA approved for the procedures used in this study.
Performing lymph node mapping and sentinel node identification during surgery in patients with endometrial cancer is considered experimental.
Up to 20 women will take part in this multicenter study. Up to 10 will be enrolled at M. D. Anderson.
- Conditions
- Endometrial Cancer
- Being tested
- Intraoperative Lymphatic Mapping
- Keywords
- Endometrial Cancer, Lymphatic Mapping, Sentinel Node Identification, Lymph Node, Intraoperative lymphatic mapping, Total hysterectomy, Bilateral salpingooophorectomy, Lymph node staging, Laparotomy, Laparoscopy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Lymphatic MappingProcedure or surgery
Intraoperative hysteroscopic injection of patent blue dye and radiocolloid for detection of sentinel lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Lymphatic Mapping | Experimental | Intraoperative sentinel lymph node identification (lymphatic mapping) Receives: Procedure: Intraoperative Lymphatic Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel Node Identification Rate
Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.
Measured: 15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startApr 2008
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: Slow accrual.
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 Endometrial 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael M. Frumovitz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671606
- Sponsor's protocol ID
- 2007-0206
- Status last verified
- Apr 2012
- First submitted
- 29 Apr 2008
- Last updated
- 27 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer
- ClinicalTrials.gov ID
- NCT00671606
- Acronym / sponsor ID
- 2007-0206
- Conditions
- Endometrial Cancer
- Keywords
- Endometrial Cancer, Lymphatic Mapping, Sentinel Node Identification, Lymph Node, Intraoperative lymphatic mapping, Total hysterectomy, Bilateral salpingooophorectomy, Lymph node staging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Posted 27 Jul 2011
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 learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer.
Detailed description
Experimental Procedures:
Lymph nodes are oval-shaped glands where immune reactions occur. For patients with endometrial cancer, lymph node status is an important factor for planning the cancer treatment course and predicting the status of the cancer. The "sentinel" node is the lymph node closest to the main tumor area, and it is believed to be at greatest risk for spread of the cancer. If the sentinel node does not contain cancer cells, then the remaining lymph nodes are usually cancer-free.
In this study, researchers want to study possibly using lymphatic mapping in future patients as an alternative to completely removing the lymph nodes in the pelvis (hip area) and para-aortic (upper abdomen) area.
Intraoperative sentinel lymph node identification (lymphatic mapping) uses 2 techniques. The first technique involves injecting a small amount of weak radioactive material, and the second involves injecting a drug called isosulfan blue or methylene blue. These techniques are being studied to see if the surgeon can locate ("map") lymph nodes that may contain tumor cells.
Routine Surgical Treatment:
As part of routine care, all participants in this study will have surgery to remove the uterus, cervix, 1-2 inches of the vagina, fallopian tubes, ovaries, and the lymph nodes in 2 areas of the waist.
Study Procedures:
If you agree to take part in this study, after you have been given the anesthetic for your surgery, your uterus will be examined to locate the tumor(s). After the tumor(s) are located, they will be injected with a radioactive substance called Tc-99m sulfur colloid. The tumors will then be injected with a dye called isosulfan blue or methylene blue, which is used to turn the sentinel node blue.
Before and during your surgery, a gamma counter (a special hand-held instrument that measures radioactivity) will be used to identify lymph nodes that have absorbed the Tc-99m sulfur colloid. The surgeon will also be able to see the lymph nodes that have absorbed the blue dye.
Information Collection:
In addition to the study procedures, researchers will collect clinical information about you that will be compared with the study results. This information includes your date of birth, age, race, height, weight, number of any past pregnancies and deliveries, any other medical conditions, and any earlier surgeries. It also includes the date of the cancer diagnosis, the status of the cancer diagnosis before surgery, the status of the disease, and the results of routine scans before surgery (chest x-ray and computed tomography [CT] or magnetic resonance imaging [MRI] scan, if performed).
Length of Study Participation:
Your participation in this study will be over after the 15-20 minute procedure for identifying the sentinel nodes. The routine surgery will occur after that, which can take up to 5 hours.
This is an investigational study. Tc-99m sulfur colloid, the blue dye (either isosulfan blue or methylene blue), and the gamma counter are FDA approved for the procedures used in this study.
Performing lymph node mapping and sentinel node identification during surgery in patients with endometrial cancer is considered experimental.
Up to 20 women will take part in this multicenter study. Up to 10 will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Lymphatic Mapping | Experimental | Procedure: Intraoperative Lymphatic MappingIntraoperative sentinel lymph node identification (lymphatic mapping) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with biopsy confirmed endometrial cancer who have been dispositioned to undergo total hysterectomy, bilateral salpingooophorectomy and lymph node staging.
- Surgical procedures may be performed by either laparotomy or laparoscopy.
- If computed tomography, magnetic resonance imaging, lymphangiography, or ultrasound has been performed for preoperative assessment, there must be no evidence of metastases. Imaging is not mandatory.
- Patients who have signed an approved informed consent and authorization permitting release of personal health information.
Key exclusion criteria (8 listed)
- Patients with a preoperative diagnosis of grade I endometrioid adenocarcinoma of the uterus.
- Patients with uterine papillary serous carcinoma.
- Patients who have undergone endometrial ablation or a myomectomy within 1 year of the surgery for endometrial cancer.
- Patients with known allergies to triphenylmethane compounds or technetium-99 radiocolloid.
- Patients with a history of retroperitoneal surgery.
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 |
|---|---|---|
| Intraoperative Lymphatic MappingIntraoperative hysteroscopic injection of patent blue dye and radiocolloid for detection of sentinel lymph nodes. | Procedure or surgery | Intraoperative Lymphatic Mapping |
Primary outcome
Sentinel Node Identification Rate
Time frame: 15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes
Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
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.
Michael M. Frumovitz, MD principal investigator
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 2 study testing Intraoperative Lymphatic Mapping in people with Endometrial 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 4 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: stopped early, as of the sponsor's last update on 27 May 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2011). 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?
Sentinel Node Identification Rate (time frame: 15-20 minute procedure prior to/during routine surgery for identifying the sentinel nodes). 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 27 May 2016.