Breast NeoplasmMaCTADNCT05427071
Magnetic Marker Localization for Occult Breast Cancer and Target Axillary Dissection in Node-positive Breast Cancer Post-neoadjuvant Chemotherapy
A study testing Magnetic seed localization in people with Breast Neoplasm and Chemotherapy Effect, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The use of neoadjuvant chemotherapy in breast cancer is expanding in the recent decade. Patients with good response to neoadjuvant chemotherapy could benefit from de-escalation of breast and axilla operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm, Chemotherapy Effect
- What is being tested?
- Magnetic seed localization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Oct 2020to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All patients with cT1-3N1 invasive ductal carcinoma planned for neoadjuvant chemotherapy and/or target therapy
- mentally competent to give informed consent
- Agreed to proceed with curative operation after chemotherapy and tentatively keen for breast conservative surgery and targeted axillary dissection after neoadjuvant chemotherapy
- Radiologically 1-3 ipsilateral axillary lymph node metastases confirmed by cytology or biopsy
Who cannot join
- Presence of distant metastasis, inflammatory breast cancers, multi-centric breast cancers
- History of previous ipsilateral axillary surgery or irradiation
- Hypersensitivity to dextran compounds or iron
- Iron overload disease
- Pregnant or lactating patients
- Patients with pacemaker or other implantable metallic devices in chest wall or prosthesis in shoulder
- Mentally incompetent patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
University of Hong Kong
Hong Kong
Christine Chan, 852-22554765, tcc0525@hku.hk
Candy, 852-22554773, kakai@hku.hk
About this study
The use of neoadjuvant chemotherapy in breast cancer is expanding in the recent decade. Patients with good response to neoadjuvant chemotherapy could benefit from de-escalation of breast and axilla operation. However, breast tumor and involved axillary lymph node should be marked before the commencement of chemotherapy. This could facilitate subsequent operative planning and intraoperative assessment of disease response. This study aims to evaluate the feasibility of magnetic marker localization for non-palpable breast cancer and targeted axillary dissection in patients with node-positive breast cancer following neoadjuvant therapy
Read the detailed description
Eligible patients will receive ultrasound guided placement of magnetic seeds (Magseed®) within the cortex of the sampled lymph node and epicenter of the breast tumor by radiologists before commencement of neoadjuvant treatment. Chemotherapeutic regimes will be determined by oncologists in charge. During the period of neoadjuvant treatment, patients will be followed up by oncologists and surgeons with clinical assessment of tumor response according to our usual practice. After completion of neoadjuvant chemotherapy, recruited patients will receive mammography and ultrasonography assessment before surgery. Breast conservative surgery with targeted axillary dissection will be offered when feasible. In patients not suitable for breast conservative surgery, mastectomy and targeted axillary dissection with or without immediate breast reconstruction will be offered.
Patient will receive localization of previously marked axillary lymph node and breast tumor and sentinel lymph node biopsy by magnetic means completely, i.e. by the use if magnetic seeds and superparamagnetic iron oxide injection. Radioisotope with Tc-99 is injected prior to operation as backup plan for sentinel lymph node biopsy. The clipped lymph node and sentinel lymph nodes are sent for frozen section analysis. If any of the lymph nodes is positive for malignancy, axillary dissection will be performed. Similarly, the breast tumor will be resected with guidance of magnetometer and specimen mammogram will confirm the presence of tumor and magnetic seeds.
- Conditions
- Breast Neoplasm, Chemotherapy Effect
- Being tested
- Magnetic seed localization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic seed localizationDevice
Magnetic seed guided localization
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Magnetic seed guided lumpectomy and targeted axillary dissection Receives: Device: Magnetic seed localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful localization of breast tumor and axillary lymph node
Successful surgical retrieval of magnetic seed marked breast tumor and axillary lymph node in intraoperative specimen mammogram (in percentage)
Measured: At the time of operation
Secondary outcomes (4)
Percentage of patients that can avoid axillary lymph node dissection
Percentage of patients that can achieve nodal pathological complete response after neoadjuvant chemotherapy
Measured: up to 4 weeks
Percentage of successful magnetic seed guided lumpectomy
Percentage of involved or close margins in lumpectomy specimen which require re-excision
Measured: up to 4 weeks
Level of satisfaction from surgeons and radiologists
Level of satisfaction from surgeons and radiologists which will be determined by the satisfaction questionnaire
Measured: To be filled in by operating surgeons and radiologists at the time of operation or magnetic seeds placement
5-year local regional recurrence rate
5-year ipsilateral breast tumor recurrence rate and/or axillary recurrence rate
Measured: 5-year post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start15 Oct 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients received magnetic seeds guided localization of axillary lymph node and breast tumor and superparamagnetic iron oxide-guided sentinel lymph node biopsy
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Endomagnetics Ltd.
- Responsible party
- Principal investigator, Professor Ava Kwong, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427071
- Sponsor's protocol ID
- UW 20-064
- Acronym
- MaCTAD
- Status last verified
- Jun 2022
- First submitted
- 16 May 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Marker Localization for Occult Breast Cancer and Target Axillary Dissection in Node-positive Breast Cancer Post-neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT05427071
- Acronym / sponsor ID
- MaCTAD / UW 20-064
- Conditions
- Breast Neoplasm, Chemotherapy Effect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Endomagnetics Ltd.
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jun 2022 (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 use of neoadjuvant chemotherapy in breast cancer is expanding in the recent decade. Patients with good response to neoadjuvant chemotherapy could benefit from de-escalation of breast and axilla operation. However, breast tumor and involved axillary lymph node should be marked before the commencement of chemotherapy. This could facilitate subsequent operative planning and intraoperative assessment of disease response. This study aims to evaluate the feasibility of magnetic marker localization for non-palpable breast cancer and targeted axillary dissection in patients with node-positive breast cancer following neoadjuvant therapy
Detailed description
Eligible patients will receive ultrasound guided placement of magnetic seeds (Magseed®) within the cortex of the sampled lymph node and epicenter of the breast tumor by radiologists before commencement of neoadjuvant treatment. Chemotherapeutic regimes will be determined by oncologists in charge. During the period of neoadjuvant treatment, patients will be followed up by oncologists and surgeons with clinical assessment of tumor response according to our usual practice. After completion of neoadjuvant chemotherapy, recruited patients will receive mammography and ultrasonography assessment before surgery. Breast conservative surgery with targeted axillary dissection will be offered when feasible. In patients not suitable for breast conservative surgery, mastectomy and targeted axillary dissection with or without immediate breast reconstruction will be offered.
Patient will receive localization of previously marked axillary lymph node and breast tumor and sentinel lymph node biopsy by magnetic means completely, i.e. by the use if magnetic seeds and superparamagnetic iron oxide injection. Radioisotope with Tc-99 is injected prior to operation as backup plan for sentinel lymph node biopsy. The clipped lymph node and sentinel lymph nodes are sent for frozen section analysis. If any of the lymph nodes is positive for malignancy, axillary dissection will be performed. Similarly, the breast tumor will be resected with guidance of magnetometer and specimen mammogram will confirm the presence of tumor and magnetic seeds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients received magnetic seeds guided localization of axillary lymph node and breast tumor and superparamagnetic iron oxide-guided sentinel lymph node biopsy
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: Magnetic seed localizationMagnetic seed guided lumpectomy and targeted axillary dissection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with cT1-3N1 invasive ductal carcinoma planned for neoadjuvant chemotherapy and/or target therapy
- mentally competent to give informed consent
- Agreed to proceed with curative operation after chemotherapy and tentatively keen for breast conservative surgery and targeted axillary dissection after neoadjuvant chemotherapy
- Radiologically 1-3 ipsilateral axillary lymph node metastases confirmed by cytology or biopsy
Key exclusion criteria (7 listed)
- Presence of distant metastasis, inflammatory breast cancers, multi-centric breast cancers
- History of previous ipsilateral axillary surgery or irradiation
- Hypersensitivity to dextran compounds or iron
- Iron overload disease
- Pregnant or lactating patients
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 |
|---|---|---|
| Magnetic seed localizationMagnetic seed guided localization | Device | Study arm |
Primary outcome
Successful localization of breast tumor and axillary lymph node
Time frame: At the time of operation
Successful surgical retrieval of magnetic seed marked breast tumor and axillary lymph node in intraoperative specimen mammogram (in percentage)
4 secondary outcomes
Percentage of patients that can avoid axillary lymph node dissection
Time frame: up to 4 weeks
Percentage of successful magnetic seed guided lumpectomy
Time frame: up to 4 weeks
Level of satisfaction from surgeons and radiologists
Time frame: To be filled in by operating surgeons and radiologists at the time of operation or magnetic seeds placement
5-year local regional recurrence rate
Time frame: 5-year post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic seed localization in people with Breast Neoplasm and Chemotherapy Effect, run by The University of Hong Kong at 1 site in Hong Kong.
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 7 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: looking for participants now, as of the sponsor's last update on 22 Jun 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Mei Vivian Man, FCSHK, FRCSEd (852-25898116, vivian27@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful localization of breast tumor and axillary lymph node (time frame: At the time of operation). 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 22 Jun 2022.