Breast CancerNCT00438477
Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer
A study testing Isosulfan Blue, Lymphangiography and Technetium Tc 99m sulfur colloid in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread. PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Isosulfan Blue, Lymphangiography and Technetium Tc 99m sulfur colloid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Apr 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion.
- Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection.
- Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node positive for metastatic disease prior to induction chemotherapy and are then found to have grossly palpable disease but are ultrasound node negative at time of study entry.
- Patients must sign an informed consent and be registered before the procedure is performed.
Who cannot join
- A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study.
- Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node metastatic disease prior to induction chemotherapy and are then found to have grossly suspicious palpable disease and are ultrasound node positive at the time of study entry.
- Patients with known allergy to isosulfan blue dye or any related compounds.
Trial locations and contacts
1 site in 1 country.
United States1 site
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
About this study
Official title: A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With Breast Cancer
RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread.
PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.
Read the detailed description
OBJECTIVES:
- Compare subareolar injection with peritumoral injection in identifying the sentinel node during breast lymphatic mapping in patients with invasive breast cancer.
- Compare the lymphatic drainage patterns using lymphoscintigraphy of the breast with subareolar injection vs peritumoral injection.
OUTLINE: At least 2 days before scheduled surgery, patients receive technetium Tc 99m sulfur colloid by peritumoral injection followed by lymphoscintigraphy. Images are obtained at 30 minutes and after 2 and 3 hours, provided no drainage is noted. Patients then receive technetium Tc 99m sulfur colloid by subareolar injection followed by another lymphoscintigraphy.
At the time of surgery, patients receive isosulfan blue by subareolar injection. A handheld gamma probe is used to locate the sentinel node. If the sentinel node is identified, it is excised and the scheduled breast surgery is performed. If the sentinel node cannot be identified, patients undergo the scheduled breast surgery.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 12.5 months.
- Conditions
- Breast Cancer
- Being tested
- Isosulfan Blue, Lymphangiography, Technetium Tc 99m sulfur colloid
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage II breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isosulfan BlueDrug
Also called lymphazurin
At time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position.
LymphangiographyProcedure or surgery
2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast
Technetium Tc 99m sulfur colloidRadiation
At least 2 days before scheduled surgery, receive technetium Tc 99m sulfur colloid by peritumoral injection; and again the day before surgery by subareolar injection.
At the time of surgery, patients receive isosulfan blue by subareolar injection.
| Study group | Role | What they receive |
|---|---|---|
| Injection Methods | Experimental | One injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple) Receives: Drug: Isosulfan Blue; Procedure: Lymphangiography; Radiation: Technetium Tc 99m sulfur colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphatic drainage patterns as determined by peritumoral and subareolar injections
Evaluate outcome descriptively.
Measured: 12 months to collect data
Identification rate of sentinel nodes and negative predictive value associated with subareolar injection
Evaluate outcome descriptively.
Measured: 12 months to collecte data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startJun 2005
- Primary completionAug 2006
- Study completionApr 2008
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gildy V. Babiera, MD, Study chair, M.D. Anderson Cancer CenterEbrahim Delpassand, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438477
- Sponsor's protocol ID
- ID01-538
- Other IDs
- P30CA016672, MDA-ID-01538, CDR0000355838
- Status last verified
- Jul 2012
- First submitted
- 20 Feb 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Preliminary Study To Explore Subareolar Injection As The Site For Lymphatic Mapping And Sentinel Lymph Node Biopsy In Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT00438477
- Acronym / sponsor ID
- ID01-538
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage II breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 22 Feb 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.
RATIONALE: Diagnostic procedures, such as lymphoscintigraphy using an injection under the nipple or near the tumor, may help doctors find out how far the disease has spread.
PURPOSE: This clinical trial is studying two different injection methods to compare how well they find the sentinel lymph node during lymphatic mapping and sentinel lymph node biopsy in patients with invasive breast cancer.
Detailed description
OBJECTIVES:
- Compare subareolar injection with peritumoral injection in identifying the sentinel node during breast lymphatic mapping in patients with invasive breast cancer.
- Compare the lymphatic drainage patterns using lymphoscintigraphy of the breast with subareolar injection vs peritumoral injection.
OUTLINE: At least 2 days before scheduled surgery, patients receive technetium Tc 99m sulfur colloid by peritumoral injection followed by lymphoscintigraphy. Images are obtained at 30 minutes and after 2 and 3 hours, provided no drainage is noted. Patients then receive technetium Tc 99m sulfur colloid by subareolar injection followed by another lymphoscintigraphy.
At the time of surgery, patients receive isosulfan blue by subareolar injection. A handheld gamma probe is used to locate the sentinel node. If the sentinel node is identified, it is excised and the scheduled breast surgery is performed. If the sentinel node cannot be identified, patients undergo the scheduled breast surgery.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 12.5 months.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection Methods | Experimental | Drug: Isosulfan Blue, Procedure: Lymphangiography, Radiation: Technetium Tc 99m sulfur colloidOne injection site with radioactive tracer intraparenchymal/peritumoral (around the tumor), and other subareolar (around the nipple) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must have either pathologic, radiologic or clinical evidence of breast cancer with invasion, suspicious for invasion or microinvasion.
- Patients who are candidates for a total mastectomy or segmental mastectomy or axillary dissection.
- Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node positive for metastatic disease prior to induction chemotherapy and are then found to have grossly palpable disease but are ultrasound node negative at time of study entry.
- Patients must sign an informed consent and be registered before the procedure is performed.
Key exclusion criteria (3 listed)
- A pregnancy test will be required preoperatively in women of childbearing potential and patients who are pregnant will be excluded from this study.
- Patients who have undergone neoadjuvant chemotherapy who have an FNA confirmed lymph node metastatic disease prior to induction chemotherapy and are then found to have grossly suspicious palpable disease and are ultrasound node positive at the time of study entry.
- Patients with known allergy to isosulfan blue dye or any related compounds.
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 |
|---|---|---|
| Isosulfan BlueAlso: lymphazurinAt time of surgery, breast injected with 3-5 cc of isosulfan blue in subareolar or peritumoral position. | Drug | Injection Methods |
| Lymphangiography2 lymphoscintigraphy images performed following peritumoral and subareolar injection of breast | Procedure or surgery | Injection Methods |
| Technetium Tc 99m sulfur colloidAt least 2 days before scheduled surgery, receive technetium Tc 99m sulfur colloid by peritumoral injection; and again the day before surgery by subareolar injection. At the time of surgery, patients receive isosulfan blue by subareolar injection. | Radiation | Injection Methods |
Primary outcome
Lymphatic drainage patterns as determined by peritumoral and subareolar injections
Time frame: 12 months to collect data
Evaluate outcome descriptively.
Identification rate of sentinel nodes and negative predictive value associated with subareolar injection
Time frame: 12 months to collecte data
Evaluate outcome descriptively.
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 30 Jul 2012.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Breast Cancer
Not yet recruiting
Decision Support for Chemoprevention
Breast Cancer
Active, not recruiting
Improving Patient-Centered Communication in Breast Cancer Through Patient and Provider Interventions
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Not yet recruitingPhase 2
The Impact of Using Nicorandil for the Prevention of Doxorubicin-Induced Cardiotoxicity
Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy
Not yet recruiting
Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer
Breast Cancer
Active, not recruitingObservational study
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy
Breast Cancer, Lymphoma
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.
Gildy V. Babiera, MD study chair
M.D. Anderson Cancer Center
Ebrahim Delpassand, MD study chair
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 Isosulfan Blue, Lymphangiography and Technetium Tc 99m sulfur colloid in people with Breast 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 4 inclusion and 3 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 30 Jul 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?
Lymphatic drainage patterns as determined by peritumoral and subareolar injections (time frame: 12 months to collect data). The study lists 2 primary outcomes in all. 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 30 Jul 2012.