Breast CancerLABSNCT01164748
Lymphatic Mapping After Previous Breast Surgery
An observational study of Breast Cancer and Sentinel Node, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Sentinel Node
- What is being tested?
- Lymphoscintigraphy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 years and older
- Women only
- Adult, Older adult
Study population: We included patients that received BCT with SNB and/or ALND for primary breast cancer located in the upper-outer quadrant of one breast at least 3 years before this analysis. Patients were excluded if they had breast surgery for other reasons than breast cancer, had recurrent breast cancer or had a former allergic reaction to 99mTc-colloidal-albumin. 44 patients were included and were divided into two groups according to previous surgical treatment of the axilla, being the sentinel node biopsy group and the Axillary Lymph Node Dissection group
Who may be able to join
- treatment with BCT with SNB and/or ALND for primary breast cancer
- previous primary breast cancer located in the upper-outer quadrant of one breast
- Primary breast cancer treatment at least 3 years before the analysis, with or without adjuvant chemo- or hormonal therapy.
Who cannot join
- breast surgery for other reasons than breast cancer
- recurrent breast cancer
- former allergic reaction to 99mTc-colloidal albumin.
Trial locations and contacts
1 site in 1 country.
About this study
Rationale: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate staging.
Objective: To assess the technical feasibility of lymphoscintigraphy after prior breast surgery. A second goal is to investigate whether or not previous breast surgery (with or without radiotherapy) significantly changes the lymphatic drainage pathways of the breast.
- Conditions
- Breast Cancer, Sentinel Node
- Being tested
- Lymphoscintigraphy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphoscintigraphyRadiation
Also called 99mTc-colloidal-albumin
in all women a lymphoscintigraphy was done to investigate drainage patterns of a previous operated breast and axilla
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Node Biopsy | All women who has Sentinel Node Biopsy as their primary treatment of the axilla Receives: Radiation: Lymphoscintigraphy | |
| Axillary Lymph Node Dissection | All women who had Axillary Lymph Node Dissection as primary axillary treatment Receives: Radiation: Lymphoscintigraphy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164748
- Sponsor's protocol ID
- NL22080.060.08
- Acronym
- LABS
- Status last verified
- Jul 2010
- First submitted
- 16 Jul 2010
- Last updated
- 19 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphatic Mapping After Previous Breast Surgery
- ClinicalTrials.gov ID
- NCT01164748
- Acronym / sponsor ID
- LABS / NL22080.060.08
- Conditions
- Breast Cancer, Sentinel Node
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- First posted
- 19 Jul 2010 (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: Like in primary breast cancer, prognosis in recurrent breast cancer is correlated with regional lymph node status. Therefore, axillary staging may be warranted in patients with recurrent disease and intact axillary nodes, although this has not been described in guidelines yet. The lymphatic drainage pathways in the breast and/or axilla could have been changed due to prior surgery and/or radiotherapy. These aberrant drainage pathways could be detected with lymphatic mapping and sentinel node biopsy (SNB), leading to a more accurate staging.
Objective: To assess the technical feasibility of lymphoscintigraphy after prior breast surgery. A second goal is to investigate whether or not previous breast surgery (with or without radiotherapy) significantly changes the lymphatic drainage pathways of the breast.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sentinel Node Biopsy | – | Radiation: LymphoscintigraphyAll women who has Sentinel Node Biopsy as their primary treatment of the axilla |
| Axillary Lymph Node Dissection | – | Radiation: LymphoscintigraphyAll women who had Axillary Lymph Node Dissection as primary axillary treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- We included patients that received BCT with SNB and/or ALND for primary breast cancer located in the upper-outer quadrant of one breast at least 3 years before this analysis. Patients were excluded if they had breast surgery for other reasons than breast cancer, had recurrent breast cancer or had a former allergic reaction to 99mTc-colloidal-albumin. 44 patients were included and were divided into two groups according to previous surgical treatment of the axilla, being the sentinel node biopsy group and the Axillary Lymph Node Dissection group
Key inclusion criteria (3 listed)
- treatment with BCT with SNB and/or ALND for primary breast cancer
- previous primary breast cancer located in the upper-outer quadrant of one breast
- Primary breast cancer treatment at least 3 years before the analysis, with or without adjuvant chemo- or hormonal therapy.
Key exclusion criteria (3 listed)
- breast surgery for other reasons than breast cancer
- recurrent breast cancer
- former allergic reaction to 99mTc-colloidal albumin.
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 |
|---|---|---|
| LymphoscintigraphyAlso: 99mTc-colloidal-albuminin all women a lymphoscintigraphy was done to investigate drainage patterns of a previous operated breast and axilla | Radiation | Axillary Lymph Node Dissection, Sentinel Node Biopsy |
Primary outcome
Not reported in the source record.
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 19 Jul 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Sentinel Node, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 3 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 19 Jul 2010. 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 Netherlands. 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.
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 19 Jul 2010.