Breast CancerNCT02617264
Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery
A study testing SPOT in people with Breast Cancer, run by Kaplan Medical Center at 1 site in Israel.
Trial summary
To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SPOT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Mar 2017
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with findings suspicious of breast cancer (or known breast cancer) who undergo axillary lymph node biopsy
Who cannot join
- Inability to sign Informed Consent
Trial locations and contacts
1 site in 1 country.
Tanir Allweis, MD contact
Israel1 site
Kaplan Medical Center
Rehovot, 76100
Tanir M Allweis, MD, +972-50-7874268, taniral@clalit.org.il
Luda Levit, B.Sc, +972-52-6529297, ludale@clalit.org.il
About this study
To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy.
Read the detailed description
As part of the diagnostic tests for breast cancer sometimes necessary to perform a FNA or Core biopsy to a suspicious axillary lymph node.
Presently there is no possibility to identify the examined gland at the surgery. If the gland was infected it's most important to remove it.
The only technique that exists today is marking with a metal clip and the use of this technique is not profit, partly because of technical difficulties.
In this trial the investigator will use a special ink which will be injected to the axillary lymph node during the biopsy and latter on the surgery the investigator will try to assess the ability to identify the marked gland.
- Conditions
- Breast Cancer
- Being tested
- SPOT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPOTProcedure or surgery
Injecting the ink (SPOT) to the axillary lymph node prior the surgery. During the surgery the lymph nodes will be tasted to diagnose the marked node.
| Study group | Role | What they receive |
|---|---|---|
| Axillary lymph node FNA Biopsy | Experimental | A carbon compound ink (SPOT) is injected to the axillary lymph node suspected to be infected with cancer Receives: Procedure: SPOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra operative identification the Spot TM marked node at the time of surgery
Measured: Within 1 year of enrollment
Secondary outcomes (1)
Correlation between Spot TM marked lymph node and sentinel lymph node
Measured: Within 1 year of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2016 (estimated)
- Study completionMar 2017 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanir M Allweis, MD, Kaplan Medical Center
- Investigators
- Tanir Allweis, MD, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617264
- Sponsor's protocol ID
- KaplanMC
- Status last verified
- Dec 2015
- First submitted
- 26 Oct 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spot tm Tattooing of Biopsied Axillary Lymph Nodes With Ultrasound Guided in Breast Cancer Patients Prior to Surgery
- ClinicalTrials.gov ID
- NCT02617264
- Acronym / sponsor ID
- KaplanMC
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 30 Nov 2015 (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.
To assess feasibility and clinical utility of marking biopsied axillary lymph nodes with Spot at time of biopsy.
Detailed description
As part of the diagnostic tests for breast cancer sometimes necessary to perform a FNA or Core biopsy to a suspicious axillary lymph node.
Presently there is no possibility to identify the examined gland at the surgery. If the gland was infected it's most important to remove it.
The only technique that exists today is marking with a metal clip and the use of this technique is not profit, partly because of technical difficulties.
In this trial the investigator will use a special ink which will be injected to the axillary lymph node during the biopsy and latter on the surgery the investigator will try to assess the ability to identify the marked gland.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axillary lymph node FNA Biopsy | Experimental | Procedure: SPOTA carbon compound ink (SPOT) is injected to the axillary lymph node suspected to be infected with cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with findings suspicious of breast cancer (or known breast cancer) who undergo axillary lymph node biopsy
Key exclusion criteria (1 listed)
- Inability to sign Informed Consent
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 |
|---|---|---|
| SPOTInjecting the ink (SPOT) to the axillary lymph node prior the surgery. During the surgery the lymph nodes will be tasted to diagnose the marked node. | Procedure or surgery | Axillary lymph node FNA Biopsy |
Primary outcome
Intra operative identification the Spot TM marked node at the time of surgery
Time frame: Within 1 year of enrollment
1 secondary outcome
Correlation between Spot TM marked lymph node and sentinel lymph node
Time frame: Within 1 year of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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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.
Tanir Allweis, MD contact
Tanir Allweis, MD principal investigator
Kaplan Medical 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 SPOT in people with Breast Cancer, run by Kaplan Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanir Allweis, MD (taniral@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra operative identification the Spot TM marked node at the time of surgery (time frame: Within 1 year of enrollment). 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 Dec 2015.