Vaginal CancerNCT00528034
Lymphoscintigraphy in Patients With Vaginal Cancer
A study testing Lymphoscintigraphy in people with Vaginal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. Determine the feasibility of using pretreatment lymphoscintigraphy to identify the sentinel lymph node(s) in patients with vaginal cancer dispositioned to receive radiation therapy. 2. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Vaginal Cancer
- What is being tested?
- Lymphoscintigraphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to May 2008
- 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 must have invasive vaginal cancer, any histology, any stage.
- Patients with prior excision of the primary are eligible.
- Patients with recurrent vaginal cancer who have not had a prior inguinal or groin lymph node dissection.
- Patients undergoing either surgical resection and assessment of inguinal or groin lymph nodes, radiation therapy and/or chemotherapy.
- Patients must sign an IRB approved informed consent.
Who cannot join
- Known allergy to triphenylmethane compounds.
- Pregnancy.
- Prior radiation therapy to the vagina, vulva, groin or pelvis.
- Prior inguinal, femoral or pelvic lymphadenectomy.
- Patients who are not good surgical candidates.
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Lymphoscintigraphy and Selective Lymphatic Mapping in Patients With Invasive Vaginal Cancer
Primary Objectives:
- Determine the feasibility of using pretreatment lymphoscintigraphy to identify the sentinel lymph node(s) in patients with vaginal cancer dispositioned to receive radiation therapy.
- Determine the feasibility of using preoperative lymphoscintigraphy and intraoperative lymphatic mapping to identify the sentinel lymph node(s) in patients with vaginal cancer dispositioned to undergo surgery and bilateral lymph node dissection.
Read the detailed description
The treatment of vaginal cancer is usually surgical removal of the vaginal tumor with removal of lymph nodes in the groin and/or pelvis. Patients who are not eligible to receive surgery usually receive radiation therapy.
Lymph nodes are a common site for the spread of vaginal cancer. Lymphatic mapping has been used in patients with other types of cancer to identify the "sentinel" lymph node. The sentinel lymph node is the lymph node 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 almost always cancer free.
This research study will find out if the sentinel node concept can be applied to patients with vaginal cancer. The sentinel lymph node will be identified using a scan called "lymphoscintigraphy". A very small amount (less than one tenth of a teaspoon) of a radioactive material is injected around the edge of the tumor in the vagina, followed immediately by the scan. The scan is done in the Nuclear Medicine Department of M. D. Anderson before the patient has surgery or begins radiation therapy.
The dose of radiation injected into the vagina is much less than the dose received from a chest x-ray and therefore there are no special precautions needed after the injection. If the treatment plan is surgery, a second injection of the radioactive material may be necessary on the day of the operation because the radiation fades quickly. Patients who receive radiation therapy will not need a second injection. The radiation oncologist might use the information collected from the scan to help with treatment planning.
For patients having surgery, a special hand held instrument that measures radioactivity (similar to a Geiger counter) is used to help identify the location of the sentinel lymph node before and after the operation begins. Blue dye is also used to find the sentinel node. This requires the injection of up to a teaspoon of material called Isosulfan Blue around the tumor in the vagina. This is done while the patient is under anesthesia. The surgeon can then identify the sentinel node by its color (blue) and by its level of radioactivity (using the gamma counter).
Patients will be notified of the results of the mapping and lymphoscintigraphy during their hospitalization or their first clinic visit, depending on whether or not they had surgery.
This is an investigational study. Eighteen patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Vaginal Cancer
- Being tested
- Lymphoscintigraphy
- Keywords
- Vaginal Cancer, Lymphoscintigraphy, Lymphatic Mapping, Sentinel Lymph Node, Isosulfan Blue, Lymph
- Medical subject headings
- Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphoscintigraphyProcedure or surgery
Procedure where a very small amount (less than one tenth of a teaspoon) of a radioactive material is injected around the edge of the tumor in the vagina, followed immediately by the scan. The scan is done before the patient has surgery or begins radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Lymphoscintigraphy | Experimental | Not described Receives: Procedure: Lymphoscintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of sentinel lymph node(s) in patients with vaginal cancer using lymphoscintigraphy and intraoperative lymphatic mapping.
Measured: Preoperative and intraoperative, prior to radiation therapy, data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startSep 2002
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Levenback, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528034
- Sponsor's protocol ID
- ID02-239
- Status last verified
- Jul 2012
- First submitted
- 10 Sep 2007
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Frumovitz M, Gayed IW, Jhingran A, Euscher ED, Coleman RL, Ramirez PT, Levenback CF. Lymphatic mapping and sentinel lymph node detection in women with vaginal cancer. Gynecol Oncol. 2008 Mar;108(3):478-81. doi: 10.1016/j.ygyno.2007.12.001. Epub 2008 Jan 10.
PubMed 18190952
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphoscintigraphy and Selective Lymphatic Mapping in Patients With Invasive Vaginal Cancer
- ClinicalTrials.gov ID
- NCT00528034
- Acronym / sponsor ID
- ID02-239
- Conditions
- Vaginal Cancer
- Keywords
- Vaginal Cancer, Lymphoscintigraphy, Lymphatic Mapping, Sentinel Lymph Node, Isosulfan Blue, Lymph
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 11 Sep 2007 (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.
Primary Objectives:
- Determine the feasibility of using pretreatment lymphoscintigraphy to identify the sentinel lymph node(s) in patients with vaginal cancer dispositioned to receive radiation therapy.
- Determine the feasibility of using preoperative lymphoscintigraphy and intraoperative lymphatic mapping to identify the sentinel lymph node(s) in patients with vaginal cancer dispositioned to undergo surgery and bilateral lymph node dissection.
Detailed description
The treatment of vaginal cancer is usually surgical removal of the vaginal tumor with removal of lymph nodes in the groin and/or pelvis. Patients who are not eligible to receive surgery usually receive radiation therapy.
Lymph nodes are a common site for the spread of vaginal cancer. Lymphatic mapping has been used in patients with other types of cancer to identify the "sentinel" lymph node. The sentinel lymph node is the lymph node 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 almost always cancer free.
This research study will find out if the sentinel node concept can be applied to patients with vaginal cancer. The sentinel lymph node will be identified using a scan called "lymphoscintigraphy". A very small amount (less than one tenth of a teaspoon) of a radioactive material is injected around the edge of the tumor in the vagina, followed immediately by the scan. The scan is done in the Nuclear Medicine Department of M. D. Anderson before the patient has surgery or begins radiation therapy.
The dose of radiation injected into the vagina is much less than the dose received from a chest x-ray and therefore there are no special precautions needed after the injection. If the treatment plan is surgery, a second injection of the radioactive material may be necessary on the day of the operation because the radiation fades quickly. Patients who receive radiation therapy will not need a second injection. The radiation oncologist might use the information collected from the scan to help with treatment planning.
For patients having surgery, a special hand held instrument that measures radioactivity (similar to a Geiger counter) is used to help identify the location of the sentinel lymph node before and after the operation begins. Blue dye is also used to find the sentinel node. This requires the injection of up to a teaspoon of material called Isosulfan Blue around the tumor in the vagina. This is done while the patient is under anesthesia. The surgeon can then identify the sentinel node by its color (blue) and by its level of radioactivity (using the gamma counter).
Patients will be notified of the results of the mapping and lymphoscintigraphy during their hospitalization or their first clinic visit, depending on whether or not they had surgery.
This is an investigational study. Eighteen patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoscintigraphy | Experimental | Procedure: Lymphoscintigraphy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must have invasive vaginal cancer, any histology, any stage.
- Patients with prior excision of the primary are eligible.
- Patients with recurrent vaginal cancer who have not had a prior inguinal or groin lymph node dissection.
- Patients undergoing either surgical resection and assessment of inguinal or groin lymph nodes, radiation therapy and/or chemotherapy.
- Patients must sign an IRB approved informed consent.
Key exclusion criteria (5 listed)
- Known allergy to triphenylmethane compounds.
- Pregnancy.
- Prior radiation therapy to the vagina, vulva, groin or pelvis.
- Prior inguinal, femoral or pelvic lymphadenectomy.
- Patients who are not good surgical candidates.
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 |
|---|---|---|
| LymphoscintigraphyProcedure where a very small amount (less than one tenth of a teaspoon) of a radioactive material is injected around the edge of the tumor in the vagina, followed immediately by the scan. The scan is done before the patient has surgery or begins radiation therapy. | Procedure or surgery | Lymphoscintigraphy |
Primary outcome
Identification of sentinel lymph node(s) in patients with vaginal cancer using lymphoscintigraphy and intraoperative lymphatic mapping.
Time frame: Preoperative and intraoperative, prior to radiation therapy, data collection
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 1 Aug 2012.
- Results publication: PubMed 18190952Frumovitz M, Gayed IW, Jhingran A, Euscher ED, Coleman RL, Ramirez PT, Levenback CF. Lymphatic mapping and sentinel lymph node detection in women with vaginal cancer. Gynecol Oncol. 2008 Mar;108(3):478-81. doi: 10.1016/j.ygyno.2007.12.001. Epub 2008 Jan 10.
- 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.
Charles Levenback, 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 Lymphoscintigraphy in people with Vaginal 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 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 1 Aug 2012. 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?
Identification of sentinel lymph node(s) in patients with vaginal cancer using lymphoscintigraphy and intraoperative lymphatic mapping. (time frame: Preoperative and intraoperative, prior to radiation therapy, data collection). 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 NCT00528034, which also lists 1 linked publication.
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 1 Aug 2012.