Breast CancerNCT05836337
Clinical Trial Evaluating the Effectiveness of a Tattoo Compared to a Clip Applied to Axillary Lymph Nodes in Breast Cancer Patients Who Undergo SLNBx
A study testing Tattoo- Black Eye and clip- HydroMARK in people with Breast Cancer, run by King Hussein Cancer Center at 1 site in Jordan.
Trial summary
This study is a single-center prospective, randomized and quasi double blinded pilot study. The study has 2 parallel arms, each arm involved around 54 patients. Targeted community is the newly diagnosed adults with non metastatic and non inflammatory breast cancer in King Hussein Cancer Center who require axillary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tattoo- Black Eye and clip- HydroMARK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteJordan
- Study dates
- 1 Feb 2017to 20 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Diagnosed with breast cancer.
- Scheduled for primary breast surgery with Sentinel Lymph node biopsy (SLNBx) or Axillary Lymph node dissection (ALND).
- Scheduled to undergo pre-operative axillary lymph node biopsy.
- Willing to sign the Informed Consent
Who cannot join
- Previous axillary surgeries, SLNBx and/or AD.
- Diagnosed with inflammatory breast cancer.
- Diagnosed with distant metastases.
- Known to have any allergic reaction to any of the investigational products.
- Participating in other studies involving investigational drug(s) (Phases 1-4) within 3 months prior to this study start and/or during study participation.
- Pregnant females or those with a positive pregnancy test result at screening or baseline; breastfeeding females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Tattoo or a Clip? A Single-center Prospective Quasi Double-blind Randomized Parallel Two-arm Clinical Trial Evaluating the Effectiveness of a Tattoo Compared to a Clip Applied to Axillary Lymph Nodes in Breast Cancer Patients Who Undergo Sentinel Lymph Node Biopsy- SLNBx
This study is a single-center prospective, randomized and quasi double blinded pilot study. The study has 2 parallel arms, each arm involved around 54 patients. Targeted community is the newly diagnosed adults with non metastatic and non inflammatory breast cancer in King Hussein Cancer Center who require axillary biopsy as part of their staging work up. The study aims to improve the intra-operative identification of the preoperatively suspicious and biopsied lymph nodes and test the concordance between the pre-operative clinical suspicion and histopathological results of these node; by comparing between preoperative marking of biopsied axillary lymph nodes with two different modalities (clipping Vs tattooing) and testing its concordance with sentinel lymph node biopsy, both in upfront surgery and neoadjuvant chemotherapy settings and in a prospective, randomized and quasi double blinded design
Read the detailed description
This study is a single-center prospective, randomized and quasi double blinded pilot study. The study will enclose 2 parallel arms, each arm will involve 54 patients (total 108 patients), comparing between preoperative marking of biopsied axillary lymph nodes with two different modalities (clipping Vs tattooing) and testing its concordance with sentinel lymph node biopsy, both in upfront surgery and neoadjuvant chemotherapy settings and in a prospective, randomized and quasi double blinded design.
Targeted community is the newly diagnosed adults (more than 18 years of age) with non metastatic and non inflammatory breast cancer in King Hussein Cancer Center who require axillary biopsy as part of their staging work up.
The standards of breast cancer care in KHCC state that all patients are required to do breast and axillary staging via clinical examination and imaging (mammogram and U/S), and require any patient with clinically suspicious axillary lymph node/nodes to undergo U/S guided axillary biopsy. Patients with negative axillary biopsy will require axillary sentinel lymph node biopsy and patients having positive axillary lymph node biopsy will require axillary clearance along with their standard breast cancer surgical treatment.
Once the need for axillary biopsy is defined, the patients offered to participate in the study in a proper environment and their consent was gained after their approval. Participants were given another appointment few days later to obtain the axillary biopsy (as per the routine in the KHCC Breast Imaging Unit) and to mark the biopsied axillary lymph node in the same session, and on that day consented participants were randomized to either axillary lymph node clip placement or tattooing after obtaining the intended axillary biopsy.
Depending on the results of the biopsy, the KHCC breast MDC decided on the surgical management including the axillary treatment, the latter will be either sentinel lymph node biopsy (SLNBx)or axillary lymph node dissection (ALND). SLNBx will be performed on all recruited patients and to be followed by the standard axillary treatment as approved by KHCC clinical practice guidelines (either SLNBx alone or SLNBx followed by ALND). The group of patients with preoperative diagnosis of positive axillary nodes with undergo SLNBx as an extra procedure to test the study hypothesis and to be followed by ALND as per the KHCC protocol. The presence of the marking material will be confirmed prior to sending the SLNBx to the pathology department (by visualization of the tattoo and by X-ray examination of SLNBx looking for the clip). Patients whom receive ALND will have the presence of marking material checked in their specimens as well. This trial will study the concordance of both marking modalities with SLNBx identification
- Conditions
- Breast Cancer
- Being tested
- Tattoo- Black Eye, clip- HydroMARK
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tattoo- Black EyeDevice
Device name: Black eye Manufacturer: The Standard Co., Ltd
clip- HydroMARKDevice
Device name: HydroMARK Manufacturer: Biopsy Sciences, LLC
| Study group | Role | What they receive |
|---|---|---|
| Tattoo- Black Eye | Experimental | to mark the biopsied axillary lymph node by tattooing Receives: Device: Tattoo- Black Eye |
| clip- HydroMARK | Active comparator | To mark the biopsied axillary lymph node by clip placement Receives: Device: clip- HydroMARK |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing effectiveness of tattooing versus clipping in SLNBx identification in breast cancer patients in upfront surgery setting, by comparing no. of identified positive or negative intraoperative SLN that were marked with tattooing versus clipping
To compare the effectiveness of tattooing compared to clipping in SLNBx identification in breast cancer patients in the upfront surgery and neoadjuvant setting, by comparing the number of identified positive or negative intraoperative SLN that were marked with the tattooing technique with the clip technique
Measured: 3 years
Secondary outcomes (3)
convenience for radiologist to apply clip or tattoo from time and technical perspectives by comparing time spent in applying clip or tattoo and convenience of the application using a questionnaire completed by radiologists after each application
The convenience for the radiologist to apply the clip or tattoo from time and technical perspectives by comparing time spent in applying the clip and tattoo as well as convenience of the application using a questionnaire completed by radiologists after each application
Measured: 3 years
convenience for surgeon to perform SLNBx after lymph node marking from time & technical perspectives by comparing time and ease to identify the marked lymph nodes during surgery using a questionnaire completed by surgeons after each surgery
The convenience for the surgeon to perform the SLNBx after the lymph node marking from time and technical perspectives by comparing the time and ease to identify the marked lymph nodes during the surgery using a questionnaire completed by surgeons after each surgery
Measured: 3 years
The convenience for the surgeon to confirm clip or tattoo presence during the SLNBx from time and technical perspectives using a questionnaire completed by surgeons after each surgery
The convenience for the surgeon to confirm clip or tattoo presence during the SLNBx from time and technical perspectives using a questionnaire completed by surgeons after each surgery
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Feb 2017
- Primary completion20 Nov 2019
- Study completion20 Aug 2020
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-center prospective, randomized and quasi double blinded pilot study. The study includes 2 parallel arms
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Hussein Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Mahmoud Al-Masri, MD, Principal investigator, King Hussein Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836337
- Sponsor's protocol ID
- 16 KHCC 84
- Status last verified
- Apr 2023
- First submitted
- 16 Apr 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tattoo or a Clip? A Single-center Prospective Quasi Double-blind Randomized Parallel Two-arm Clinical Trial Evaluating the Effectiveness of a Tattoo Compared to a Clip Applied to Axillary Lymph Nodes in Breast Cancer Patients Who Undergo Sentinel Lymph Node Biopsy- SLNBx
- ClinicalTrials.gov ID
- NCT05836337
- Acronym / sponsor ID
- 16 KHCC 84
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- King Hussein Cancer CenterUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 1 May 2023 (actual)
- 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.
This study is a single-center prospective, randomized and quasi double blinded pilot study. The study has 2 parallel arms, each arm involved around 54 patients. Targeted community is the newly diagnosed adults with non metastatic and non inflammatory breast cancer in King Hussein Cancer Center who require axillary biopsy as part of their staging work up. The study aims to improve the intra-operative identification of the preoperatively suspicious and biopsied lymph nodes and test the concordance between the pre-operative clinical suspicion and histopathological results of these node; by comparing between preoperative marking of biopsied axillary lymph nodes with two different modalities (clipping Vs tattooing) and testing its concordance with sentinel lymph node biopsy, both in upfront surgery and neoadjuvant chemotherapy settings and in a prospective, randomized and quasi double blinded design
Detailed description
This study is a single-center prospective, randomized and quasi double blinded pilot study. The study will enclose 2 parallel arms, each arm will involve 54 patients (total 108 patients), comparing between preoperative marking of biopsied axillary lymph nodes with two different modalities (clipping Vs tattooing) and testing its concordance with sentinel lymph node biopsy, both in upfront surgery and neoadjuvant chemotherapy settings and in a prospective, randomized and quasi double blinded design.
Targeted community is the newly diagnosed adults (more than 18 years of age) with non metastatic and non inflammatory breast cancer in King Hussein Cancer Center who require axillary biopsy as part of their staging work up.
The standards of breast cancer care in KHCC state that all patients are required to do breast and axillary staging via clinical examination and imaging (mammogram and U/S), and require any patient with clinically suspicious axillary lymph node/nodes to undergo U/S guided axillary biopsy. Patients with negative axillary biopsy will require axillary sentinel lymph node biopsy and patients having positive axillary lymph node biopsy will require axillary clearance along with their standard breast cancer surgical treatment.
Once the need for axillary biopsy is defined, the patients offered to participate in the study in a proper environment and their consent was gained after their approval. Participants were given another appointment few days later to obtain the axillary biopsy (as per the routine in the KHCC Breast Imaging Unit) and to mark the biopsied axillary lymph node in the same session, and on that day consented participants were randomized to either axillary lymph node clip placement or tattooing after obtaining the intended axillary biopsy.
Depending on the results of the biopsy, the KHCC breast MDC decided on the surgical management including the axillary treatment, the latter will be either sentinel lymph node biopsy (SLNBx)or axillary lymph node dissection (ALND). SLNBx will be performed on all recruited patients and to be followed by the standard axillary treatment as approved by KHCC clinical practice guidelines (either SLNBx alone or SLNBx followed by ALND). The group of patients with preoperative diagnosis of positive axillary nodes with undergo SLNBx as an extra procedure to test the study hypothesis and to be followed by ALND as per the KHCC protocol. The presence of the marking material will be confirmed prior to sending the SLNBx to the pathology department (by visualization of the tattoo and by X-ray examination of SLNBx looking for the clip). Patients whom receive ALND will have the presence of marking material checked in their specimens as well. This trial will study the concordance of both marking modalities with SLNBx identification
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a single-center prospective, randomized and quasi double blinded pilot study. The study includes 2 parallel arms
| Arm | Type | Receives |
|---|---|---|
| Tattoo- Black Eye | Experimental | Device: Tattoo- Black Eyeto mark the biopsied axillary lymph node by tattooing |
| clip- HydroMARK | Active comparator | Device: clip- HydroMARKTo mark the biopsied axillary lymph node by clip placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Diagnosed with breast cancer.
- Scheduled for primary breast surgery with Sentinel Lymph node biopsy (SLNBx) or Axillary Lymph node dissection (ALND).
- Scheduled to undergo pre-operative axillary lymph node biopsy.
- Willing to sign the Informed Consent
Key exclusion criteria (6 listed)
- Previous axillary surgeries, SLNBx and/or AD.
- Diagnosed with inflammatory breast cancer.
- Diagnosed with distant metastases.
- Known to have any allergic reaction to any of the investigational products.
- Participating in other studies involving investigational drug(s) (Phases 1-4) within 3 months prior to this study start and/or during study participation.
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 |
|---|---|---|
| Tattoo- Black EyeDevice name: Black eye Manufacturer: The Standard Co., Ltd | Device | Tattoo- Black Eye |
| clip- HydroMARKDevice name: HydroMARK Manufacturer: Biopsy Sciences, LLC | Device | clip- HydroMARK |
Primary outcome
comparing effectiveness of tattooing versus clipping in SLNBx identification in breast cancer patients in upfront surgery setting, by comparing no. of identified positive or negative intraoperative SLN that were marked with tattooing versus clipping
Time frame: 3 years
To compare the effectiveness of tattooing compared to clipping in SLNBx identification in breast cancer patients in the upfront surgery and neoadjuvant setting, by comparing the number of identified positive or negative intraoperative SLN that were marked with the tattooing technique with the clip technique
3 secondary outcomes
convenience for radiologist to apply clip or tattoo from time and technical perspectives by comparing time spent in applying clip or tattoo and convenience of the application using a questionnaire completed by radiologists after each application
Time frame: 3 years
convenience for surgeon to perform SLNBx after lymph node marking from time & technical perspectives by comparing time and ease to identify the marked lymph nodes during surgery using a questionnaire completed by surgeons after each surgery
Time frame: 3 years
The convenience for the surgeon to confirm clip or tattoo presence during the SLNBx from time and technical perspectives using a questionnaire completed by surgeons after each surgery
Time frame: 3 years
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 May 2023.
- Individual participant dataSharing planned: No
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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.
Dr. Mahmoud Al-Masri, MD principal investigator
King Hussein 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 Tattoo- Black Eye and clip- HydroMARK in people with Breast Cancer, run by King Hussein Cancer Center at 1 site in Jordan.
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 6 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 May 2023. 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 Jordan. 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?
comparing effectiveness of tattooing versus clipping in SLNBx identification in breast cancer patients in upfront surgery setting, by comparing no. of identified positive or negative intraoperative SLN that were marked with tattooing versus clipping (time frame: 3 years). 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 1 May 2023.