Breast CancerPhase 3UltraCarsNCT04951245
Ultrasound-assisted CNSs Mapping Versus Dual-tracer-guided Sentinel Lymph Node Biopsy
A Phase 3 study testing UC group: ultrasound-assisted CNSs guided and GC group: CNSs plus ICG dual-tracer-guided in people with Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The investigators suggested ultrasound-assisted Carbon nanoparticle suspensions (CNSs) mapping had great clinical value in clinical application and might serve as a useful alternative to the dual-tracer-guided SLNB. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- UC group: ultrasound-assisted CNSs guided and GC group: CNSs plus ICG dual-tracer-guided
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 1 Jun 2021
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants must be female and 18 years of age or older.
- Resectable invasive adenocarcinoma of the breast, confirmed histologically.
- Ductal carcinoma in situ confirmed histologically.
- The participants must be a preoperative clinical Tis, T1, T2, T3 as well as clinical M0 breast cancer.
- Without clinical or radiological nodal involvement (cN0): No positive ipsilateral axillary lymph nodes; No prior removal of ipsilateral axillary lymph nodes; No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy.
- With clinical positive lymph nodes (cN1) (including any abnormal or enlarged clinically palpable lymph nodes or core biopsy/surgical biopsy/FNA evidence of malignant cell within any lymph nodes) that was downstaged to cN0 following neoadjuvant therapy.
- The participants must have an ECOG performance status of Grade 0-1.
- The participants must provide written informed consent before participating in the study.
Who cannot join
- The breast has ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. Tethering or dimpling of the skin or nipple inversion allowed.
- The participants has a known hypersensitivity to tracers planned for use during SLNB.
- Other prior breast malignancy except lobular carcinoma in situ.
- The participants has had prior breast implants.
- The participants has had prior breast reduction surgery.
- The participants has had other prior surgery in the upper, outer quadrant, areola, or axilla to the indicated breast.
- The participants has a positive pregnancy test or is lactating.
- The participants has participated in another investigational drug study during the 30 days prior to signing informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-assisted Carbon Nanoparticle Suspensions Mapping Versus Dual-tracer-guided Sentinel Lymph Node Biopsy in Patients With Early Breast Cancer (UltraCars): a Prospective, Randomized Controlled Phase 3 Trial
The investigators suggested ultrasound-assisted Carbon nanoparticle suspensions (CNSs) mapping had great clinical value in clinical application and might serve as a useful alternative to the dual-tracer-guided SLNB. The investigators designed this prospective, randomized controlled phase 3 trial, to compare the feasibility and diagnostic performance of ultrasound-assisted carbon nanoparticle suspensions mapping versus dual-tracer-guided sentinel lymph node biopsy in patients with early breast cancer.
Read the detailed description
The study was a single-center, open-label, randomized controlled, non-inferiority, phase 3 trial. Eligible participants were 18 year's of age or older and had histologically confirmed primary invasive breast cancer, or ductal carcinoma in situ scheduled for mastectomy, without clinical or radiological nodal involvement (cN0) or with clinical positive lymph nodes (cN1) that were downstaged to cN0 following neoadjuvant chemotherapy (NCT); and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Participants were randomly assigned (1:1) using a permuted block randomization scheme to receive either ultrasound-assisted CNSs (UC group) or CNSs plus ICG dual-tracer-guided (GC group) SLN mapping.
- Conditions
- Breast Cancer
- Being tested
- UC group: ultrasound-assisted CNSs guided, GC group: CNSs plus ICG dual-tracer-guided
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC group: ultrasound-assisted CNSs guidedProcedure or surgery
1ml of CNSs was subcutaneously injected into the areolar area in the upper outer quadrant of the breast. The injection site was massaged for 15 minutes to promote drainage of the tracer to the axilla. During the intraoperative ultrasound-assisted procedure, an ultrasound diagnostic system was used. Before the incision, ultrasound-guided exploration of SLNs was performed by placing the probe on the lateral border of the breast and sliding cranially along the lateral border of the pectoralis major muscle . A sterile skin marker was then used to mark the optimal site of incision over the targeted lymph nodes, and the distance from the skin to the nodes was measured by ultrasound and recorded in millimeters. Blunt dissection was carried out to identify the CNSs-stained nodes around the marked region. Ultrasonography probe was placed repeatedly in or around the wound at different angles for adequate visualization if SLNs could not be localized with further dissection.
GC group: CNSs plus ICG dual-tracer-guidedProcedure or surgery
The preparation of CNSs mapping was identical to that of the UC group. 1ml of diluted ICG was subsequently injected into the areolar area in the upper outer quadrant of the breast. A NIR camera was used to visualize the subcutaneous lymph vessels and localized the SLNs. All fluorescent or black-stained lymph nodes along with any palpable suspicious nodes were removed. The remaining surgical field was reexamined to ensure complete resection of fluorescent lymph nodes.
| Study group | Role | What they receive |
|---|---|---|
| UC group | Experimental | Ultrasound-assisted CNSs guided SLN mapping Receives: Procedure: UC group: ultrasound-assisted CNSs guided |
| GC group | Active comparator | CNSs plus ICG dual-tracer-guided SLN mapping Receives: Procedure: GC group: CNSs plus ICG dual-tracer-guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
The identification rate of SLNs
Defined as the number of patients who at least one SLN were detected divided by the total number of patients included.
Measured: within 14 days of SLNB
Secondary outcomes (3)
The mean number of SLNs collected
Defined as the number of tracer-stained or palpable SLNs divided by the number of patients whose SLNs were identified.
Measured: within 14 days of SLNB
Operative time
Defined as the time from skin incision to resection of the SLNs specimens in patients whose at least one SLN were detected.
Measured: within 14 days of SLNB
Intraoperative or postoperative complications
An adverse event is any untoward, undesired, and/or unplanned clinical event in the form of signs, symptoms, disease, or laboratory testing, or physiological observations occurring in a human participating in a clinical study with a study drug, regardless of causal relationship.
Measured: within 30 days of SLNB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Dec 2019
- Primary completion30 Apr 2021
- Study completion1 Jun 2021
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Wang, Guangdong Provincial People's Hospital
- Investigators
- Kun Wang, MD, Study chair, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951245
- Sponsor's protocol ID
- 20190511
- Acronym
- UltraCars
- Status last verified
- Jan 2022
- First submitted
- 21 Sep 2019
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang L, Cheng M, Lin Y, Zhang J, Shen B, Chen Y, Yang C, Yang M, Zhu T, Gao H, Ji F, Li J, Wang K. Ultrasound-assisted carbon nanoparticle suspension mapping versus dual tracer-guided sentinel lymph node biopsy in patients with early breast cancer (ultraCars): phase III randomized clinical trial. Br J Surg. 2022 Nov 22;109(12):1232-1238. doi: 10.1093/bjs/znac311.
PubMed 36074703
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted Carbon Nanoparticle Suspensions Mapping Versus Dual-tracer-guided Sentinel Lymph Node Biopsy in Patients With Early Breast Cancer (UltraCars): a Prospective, Randomized Controlled Phase 3 Trial
- ClinicalTrials.gov ID
- NCT04951245
- Acronym / sponsor ID
- UltraCars / 20190511
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 6 Jul 2021 (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.
The investigators suggested ultrasound-assisted Carbon nanoparticle suspensions (CNSs) mapping had great clinical value in clinical application and might serve as a useful alternative to the dual-tracer-guided SLNB. The investigators designed this prospective, randomized controlled phase 3 trial, to compare the feasibility and diagnostic performance of ultrasound-assisted carbon nanoparticle suspensions mapping versus dual-tracer-guided sentinel lymph node biopsy in patients with early breast cancer.
Detailed description
The study was a single-center, open-label, randomized controlled, non-inferiority, phase 3 trial. Eligible participants were 18 year's of age or older and had histologically confirmed primary invasive breast cancer, or ductal carcinoma in situ scheduled for mastectomy, without clinical or radiological nodal involvement (cN0) or with clinical positive lymph nodes (cN1) that were downstaged to cN0 following neoadjuvant chemotherapy (NCT); and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. Participants were randomly assigned (1:1) using a permuted block randomization scheme to receive either ultrasound-assisted CNSs (UC group) or CNSs plus ICG dual-tracer-guided (GC group) SLN mapping.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC group | Experimental | Procedure: UC group: ultrasound-assisted CNSs guidedUltrasound-assisted CNSs guided SLN mapping |
| GC group | Active comparator | Procedure: GC group: CNSs plus ICG dual-tracer-guidedCNSs plus ICG dual-tracer-guided SLN mapping |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The participants must be female and 18 years of age or older.
- Resectable invasive adenocarcinoma of the breast, confirmed histologically.
- Ductal carcinoma in situ confirmed histologically.
- The participants must be a preoperative clinical Tis, T1, T2, T3 as well as clinical M0 breast cancer.
- Without clinical or radiological nodal involvement (cN0): No positive ipsilateral axillary lymph nodes; No prior removal of ipsilateral axillary lymph nodes; No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven nonmalignant by biopsy.
Key exclusion criteria (8 listed)
- The breast has ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude. Tethering or dimpling of the skin or nipple inversion allowed.
- The participants has a known hypersensitivity to tracers planned for use during SLNB.
- Other prior breast malignancy except lobular carcinoma in situ.
- The participants has had prior breast implants.
- The participants has had prior breast reduction surgery.
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 |
|---|---|---|
| UC group: ultrasound-assisted CNSs guided1ml of CNSs was subcutaneously injected into the areolar area in the upper outer quadrant of the breast. The injection site was massaged for 15 minutes to promote drainage of the tracer to the axilla. During the intraoperative ultrasound-assisted procedure, an ultrasound diagnostic system was used. Before the incision, ultrasound-guided exploration of SLNs was performed by placing the probe on the lateral border of the breast and sliding cranially along the lateral border of the pectoralis major muscle . A sterile skin marker was then used to mark the optimal site of incision over the targeted lymph nodes, and the distance from the skin to the nodes was measured by ultrasound and recorded in millimeters. Blunt dissection was carried out to identify the CNSs-stained nodes around the marked region. Ultrasonography probe was placed repeatedly in or around the wound at different angles for adequate visualization if SLNs could not be localized with further dissection. | Procedure or surgery | UC group |
| GC group: CNSs plus ICG dual-tracer-guidedThe preparation of CNSs mapping was identical to that of the UC group. 1ml of diluted ICG was subsequently injected into the areolar area in the upper outer quadrant of the breast. A NIR camera was used to visualize the subcutaneous lymph vessels and localized the SLNs. All fluorescent or black-stained lymph nodes along with any palpable suspicious nodes were removed. The remaining surgical field was reexamined to ensure complete resection of fluorescent lymph nodes. | Procedure or surgery | GC group |
Primary outcome
The identification rate of SLNs
Time frame: within 14 days of SLNB
Defined as the number of patients who at least one SLN were detected divided by the total number of patients included.
3 secondary outcomes
The mean number of SLNs collected
Time frame: within 14 days of SLNB
Operative time
Time frame: within 14 days of SLNB
Intraoperative or postoperative complications
Time frame: within 30 days of SLNB
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 28 Jan 2022.
- Derived from this study: PubMed 36074703Zhang L, Cheng M, Lin Y, Zhang J, Shen B, Chen Y, Yang C, Yang M, Zhu T, Gao H, Ji F, Li J, Wang K. Ultrasound-assisted carbon nanoparticle suspension mapping versus dual tracer-guided sentinel lymph node biopsy in patients with early breast cancer (ultraCars): phase III randomized clinical trial. Br J Surg. 2022 Nov 22;109(12):1232-1238. doi: 10.1093/bjs/znac311.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Kun Wang, MD study chair
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UC group: ultrasound-assisted CNSs guided and GC group: CNSs plus ICG dual-tracer-guided in people with Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
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 8 inclusion and 8 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 28 Jan 2022. 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 China. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The identification rate of SLNs (time frame: within 14 days of SLNB). 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 NCT04951245, 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 28 Jan 2022.