Cervical CancerNCT00631241
Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer
A study testing Single Photon Emission Computed Tomography and Intraoperative Lymphatic Mapping in people with Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if the parametrial nodes are "sentinel" nodes (the lymph nodes believed to be the greatest risk for the spread of cancer) and if intraoperative lymphatic mapping can identify "sentinel" lymph nodes in the parametrium (the tissue that is on either side of the… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Single Photon Emission Computed Tomography and 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Sep 2012
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are dispositioned to undergo radical hysterectomy or radical trachelectomy and pelvic lymphadenectomy.
- No evidence of metastases on computed tomography, magnetic resonance imaging, or PET/CT scan.
- Patients must be good surgical candidates.
- Patients who have signed an approved informed consent and authorization permitting release of personal health information.
- For patients of child-bearing age, a negative serum pregnancy test within 72 hours prior to injection of radiocolloid. Child-bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.
Who cannot join
- Patients with known allergies to triphenylmethane compounds or India ink.
- Patients with a history of retroperitoneal surgery.
- Patients with a history of pelvic irradiation.
- Patients who had a cold knife or LEEP cone biopsy within 4 weeks of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histopathologic Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer Undergoing Radical Hysterectomy or Radical Trachelectomy and Pelvic Lymph Node Dissection: A Feasibility Study
The goal of this clinical research study is to find out if the parametrial nodes are "sentinel" nodes (the lymph nodes believed to be the greatest risk for the spread of cancer) and if intraoperative lymphatic mapping can identify "sentinel" lymph nodes in the parametrium (the tissue that is on either side of the cervix). Identifying these lymph nodes may help to predict the status of the remaining lymph nodes in the pelvis. This research will also determine if India Ink is safe to use with the blue dye and radioactive tracer and if it improves the process of identifying the sentinel nodes.
Read the detailed description
Lymph nodes are glands that play an important part in your body's defense against infection. They are also the most common site of cancer spread in patients with cervical cancer. Intraoperative lymphatic mapping is a procedure that has been used in patients with other types of cancer to identify the "sentinel" lymph node. Researchers know that if the sentinel node does not contain cancer, then the remaining lymph nodes are almost always cancer-free.
Researchers believe that the parametrial lymph nodes (1 group of lymph nodes located in the parametrium) are the sentinel lymph nodes in patients with cervical cancer. Surgical removal of the parametrial lymph nodes is currently the only known way to accurately find out whether or not these lymph nodes have cancer in them.
Stage IA2 or IB1 cervix cancer is treated by a radical hysterectomy (removal of the uterus, cervix, and the parametrium) or radical trachelectomy (removal of the cervix and the parametrium). Pelvic lymph nodes and possibly para-aortic lymph nodes (near the aorta in the abdomen) are also removed. This procedure is called a pelvic and para-aortic lymphadenectomy.
If you agree to take part in this study, you will undergo a procedure called intraoperative lymphatic mapping. This procedure is done in the operating room. When you are asleep (under anesthesia), the surgeon will inject the cervix with a very small amount (less than one tenth of a teaspoon) of a radioactive material in 4 different places around the edge of the tumor in the cervix. This injection is given over 1-2 minutes. The cervix is then injected with 2 different blue dyes called Isosulfan Blue and India ink (about 1 1/2 teaspoons). These injections take less than 5 minutes. The surgeon will then use a special hand-held instrument for measuring radioactivity to help find the sentinel lymph nodes before and after the operation begins. During the operation, the surgeon will also visually inspect the lymph nodes to see if they are blue (stained by the blue dye and India Ink). These 2 techniques (the radioactive material and the dye and ink) will help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.
During your hospitalization or at your first clinic visit, your doctor will tell you whether or not cancer was found in the lymph nodes that were removed during surgery.
You will be taken off study if intolerable side effects occur. You will be considered off study after your first doctor's visit after the surgery.
This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Cervical Cancer
- Being tested
- Single Photon Emission Computed Tomography, Intraoperative Lymphatic Mapping
- Keywords
- Cervical Cancer, Parametrial Lymph Nodes, Sentinel Nodes, Intraoperative Lymphatic Mapping, Single Photon Emission Computed Tomography, SPECT/CT
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Photon Emission Computed TomographyProcedure or surgery
Also called SPECT/CT
First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients.
Intraoperative Lymphatic MappingProcedure or surgery
Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Lymphatic Mapping | Experimental | Single Photon Emission Computed Tomography - First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients. Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity. Receives: Procedure: Single Photon Emission Computed Tomography; Procedure: Intraoperative Lymphatic Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with sentinel lymph nodes in the parametrium
Sentinel nodes classified according to modification of American Joint Committee on Cancer (AJCC) staging for axillary nodes from breast cancer as follows: 1) metastases present - tumor > 2.0 mm in diameter; 2) micrometastases present - tumor cell aggregates between 0.2 and 2.0 mm in diameter; 3) isolated tumor cells - individual tumor cells or aggregates <0.2 mm in diameter, usually detected by immunohistochemistry; or 4) tumor absent - no tumor cells identified in H\&E (or immunohistochemically) stained sections.
Parametrium separated from cervix/uterus by pathology then away from primary cervical lesion will be re-examined for sentinel nodes both visually \& with handheld gamma counter; \& all parametrial tissue will be submitted for pathologic sectioning to detect carbon particles in parametrial sentinel nodes not detected by gamma counter or direct visualization.
Measured: Determination during surgery (with intraoperative lymphatic mapping)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical 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 N/A
- Primary purpose
- Treatment
- 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
- Responsible party
- Sponsor
- Investigators
- Michael M. Frumovitz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631241
- Sponsor's protocol ID
- 2006-0153
- Status last verified
- Apr 2016
- First submitted
- 27 Feb 2008
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathologic Analysis of Parametrial Lymph Nodes as Sentinel Nodes in Patients With Cervical Cancer Undergoing Radical Hysterectomy or Radical Trachelectomy and Pelvic Lymph Node Dissection: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00631241
- Acronym / sponsor ID
- 2006-0153
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Parametrial Lymph Nodes, Sentinel Nodes, Intraoperative Lymphatic Mapping, Single Photon Emission Computed Tomography, SPECT/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 7 Mar 2008 (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 out if the parametrial nodes are "sentinel" nodes (the lymph nodes believed to be the greatest risk for the spread of cancer) and if intraoperative lymphatic mapping can identify "sentinel" lymph nodes in the parametrium (the tissue that is on either side of the cervix). Identifying these lymph nodes may help to predict the status of the remaining lymph nodes in the pelvis. This research will also determine if India Ink is safe to use with the blue dye and radioactive tracer and if it improves the process of identifying the sentinel nodes.
Detailed description
Lymph nodes are glands that play an important part in your body's defense against infection. They are also the most common site of cancer spread in patients with cervical cancer. Intraoperative lymphatic mapping is a procedure that has been used in patients with other types of cancer to identify the "sentinel" lymph node. Researchers know that if the sentinel node does not contain cancer, then the remaining lymph nodes are almost always cancer-free.
Researchers believe that the parametrial lymph nodes (1 group of lymph nodes located in the parametrium) are the sentinel lymph nodes in patients with cervical cancer. Surgical removal of the parametrial lymph nodes is currently the only known way to accurately find out whether or not these lymph nodes have cancer in them.
Stage IA2 or IB1 cervix cancer is treated by a radical hysterectomy (removal of the uterus, cervix, and the parametrium) or radical trachelectomy (removal of the cervix and the parametrium). Pelvic lymph nodes and possibly para-aortic lymph nodes (near the aorta in the abdomen) are also removed. This procedure is called a pelvic and para-aortic lymphadenectomy.
If you agree to take part in this study, you will undergo a procedure called intraoperative lymphatic mapping. This procedure is done in the operating room. When you are asleep (under anesthesia), the surgeon will inject the cervix with a very small amount (less than one tenth of a teaspoon) of a radioactive material in 4 different places around the edge of the tumor in the cervix. This injection is given over 1-2 minutes. The cervix is then injected with 2 different blue dyes called Isosulfan Blue and India ink (about 1 1/2 teaspoons). These injections take less than 5 minutes. The surgeon will then use a special hand-held instrument for measuring radioactivity to help find the sentinel lymph nodes before and after the operation begins. During the operation, the surgeon will also visually inspect the lymph nodes to see if they are blue (stained by the blue dye and India Ink). These 2 techniques (the radioactive material and the dye and ink) will help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity.
During your hospitalization or at your first clinic visit, your doctor will tell you whether or not cancer was found in the lymph nodes that were removed during surgery.
You will be taken off study if intolerable side effects occur. You will be considered off study after your first doctor's visit after the surgery.
This is an investigational study. Up to 20 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Lymphatic Mapping | Experimental | Procedure: Single Photon Emission Computed Tomography, Procedure: Intraoperative Lymphatic MappingSingle Photon Emission Computed Tomography - First 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients. Isosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are dispositioned to undergo radical hysterectomy or radical trachelectomy and pelvic lymphadenectomy.
- No evidence of metastases on computed tomography, magnetic resonance imaging, or PET/CT scan.
- Patients must be good surgical candidates.
- Patients who have signed an approved informed consent and authorization permitting release of personal health information.
- For patients of child-bearing age, a negative serum pregnancy test within 72 hours prior to injection of radiocolloid. Child-bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.
Key exclusion criteria (4 listed)
- Patients with known allergies to triphenylmethane compounds or India ink.
- Patients with a history of retroperitoneal surgery.
- Patients with a history of pelvic irradiation.
- Patients who had a cold knife or LEEP cone biopsy within 4 weeks of enrollment.
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 |
|---|---|---|
| Single Photon Emission Computed TomographyAlso: SPECT/CTFirst 3 Patients = Performed 30-45 minutes, 2-3 hours, and 20-24 hours after injections of the radioactive material or just before surgery; Remaining 17 Patients = Performed only one at a time as was found to be best based on the scans from first 3 patients. | Procedure or surgery | Intraoperative Lymphatic Mapping |
| Intraoperative Lymphatic MappingIsosulfan Blue and India ink will be injected into the cervix to help the surgeon identify the sentinel nodes by their blue color and their level of radioactivity. | Procedure or surgery | Intraoperative Lymphatic Mapping |
Primary outcome
Number of Patients with sentinel lymph nodes in the parametrium
Time frame: Determination during surgery (with intraoperative lymphatic mapping)
Sentinel nodes classified according to modification of American Joint Committee on Cancer (AJCC) staging for axillary nodes from breast cancer as follows: 1) metastases present - tumor > 2.0 mm in diameter; 2) micrometastases present - tumor cell aggregates between 0.2 and 2.0 mm in diameter; 3) isolated tumor cells - individual tumor cells or aggregates <0.2 mm in diameter, usually detected by immunohistochemistry; or 4) tumor absent - no tumor cells identified in H\&E (or immunohistochemically) stained sections. Parametrium separated from cervix/uterus by pathology then away from primary cervical lesion will be re-examined for sentinel nodes both visually \& with handheld gamma counter; \& all parametrial tissue will be submitted for pathologic sectioning to detect carbon particles in parametrial sentinel nodes not detected by gamma counter or direct visualization.
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 May 2016.
- UT 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.
Michael M. Frumovitz, MD 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 study testing Single Photon Emission Computed Tomography and Intraoperative Lymphatic Mapping in people with Cervical Cancer, 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 4 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 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 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?
Number of Patients with sentinel lymph nodes in the parametrium (time frame: Determination during surgery (with intraoperative lymphatic mapping)). 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 2 May 2016.