Use of Magtrace Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer

ConditionsBreast Cancer With Low to Intermediate HER2 Expression Breast Cancer (Triple Negative Breast Cancer (TNBC))Breast Cancer (Triple Negative Type)Breast Cancer - Infiltrating Ductal Carcinoma Breast Cancer - Ductal Carcinoma in Situ (DCIS)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorKing Faisal Specialist Hospital & Research Center

About this trial

Breast cancer is the commonest cancer affecting women worldwide. Early breast cancer is treated surgically with wide local excision of tumor with axillary staging operations like sentinel node biopsy. Surgical adjuncts used in identifying and localizing the area for excision include metallic wire, radioactive or magnetic seeds and radiofrequency reflectors. These are placed in the lesion under image guidance by the breast radiologists, either on the day of surgery (wires) or prior (seeds). Bracketing localization is performed in case of multiple lesions or wide spread calcifications to aid the surgeons in performing wide local excision of all involved areas. This means placing multiple devices around the area of excision for accurate triangulation, which increase the costs significantly.

Localization agents like radionucleotide labelled albumin, super paramagnetic iron oxide (SPIO) and colored dyes like methylene blue, isosulphane blue and indocyanine green are injected in the breast for identification of sentinel lymph nodes in the axilla.

More recent studies have demonstrated successful use of SPIO in localization of small impalpable breast cancer lesions. This also raises the prospect of using SPIO for the dual purpose of lesion localization / bracketing and sentinel node biopsy. This study was designed to test this principle in patients requiring bracketing.

This is a prospective proof-of-concept pilot study to evaluate the feasibility of SPIO (Magtrace®) as a single-agent solution for bracketing the excision area and localizing the sentinel lymph node for breast-conserving surgery. Patients with breast cancer requiring bracketing and sentinel node biopsy will be identified through multidisciplinary breast tumor board and invited to take part in the study. All patients who consent to participate will receive an injection of Magtrace® for bracketing (0.5ml each at four points around the excision area) one day before surgery under ultrasound guidance. Primary outcome will be successful localization of the Magtrace® signal in breast for bracketing and in the sentinel node, using a magnetic probe on the day of surgery. Clinical outcomes, complications and cost analyses will be performed as secondary outcomes. We anticipate a sample size of 35 patients to be recruited for the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients having mastectomy.

Patients unfit for breast conserving surgery due to inability to have adjuvant radiotherapy.

Patients requiring axillary clearance without sentinel node biopsy.

Patient undergoing breast conserving surgery without need for sentinel node biopsy.

Trial design

Design model

Single group

Treatments tested in this trial

Super paramagnetic iron oxide bracketing injection
Other intervention
Lesion localization procedure will be performed one day before or on the day of surgery. Patients included in the study will have localization of primary cancer / cancers with Magseed® and bracketing with Magtrace® under ultrasound / Mammographic guidance as indicated, in accordance with the local treatment protocol. The Consultant Radiologist using Magtrace® will perform bracketing under image guidance. 0.5ml of Magtrace® will be injected into the breast parenchyma superior, inferior, medial and lateral to the area planned for excision.

Treatment groups

35 Participants

are divided into 1 treatment group

Group A: Magtrace BracketingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Success localization of bracketing Magtrace injection with Magnetic probe

A hand held magnetic localization probe (Sentimag) will be used on the morning of surgery by the operating surgeon to localize the signal of Magtrace at four points bracketed around the area of the breast to be excised. For the bracketing localization to be considered successful, signal localization will be required to be present at all four points.

Time frame

Morning of surgery.

Secondary outcomes

Successful sentinel node localization with Magnetic probe

Hand held magnetic signal localization probe (Sentimag) will be used to localize Magtrace signal intra-operatively in the ipsilateral axillary lymph node for them to be labelled as sentinel lymph nodes. Second localization agent (Methylene blue) will also be injected in the breast on the morning of surgery as per protocol for dual localization of sentinel nodes. Absence of magnetic signal or blue dye in the lymph nodes will be considered as failure of sentinel node localization.

Time frame

Time of surgery

Duration of surgery

Total duration of surgery from skin incision to complete skin closure and application of dressing will be noted in minutes.

Time frame

Time of surgery

Breast tissue resection weight and volume

Tissue removed at the time of surgery will be weighed using electronic scale in grams. Tissue volume will be calculated based on gross pathology description of the length, breadth and depth of the specimen at the time of cross sectional cutting of specimen for fixation immediately after removal of specimen from the breast.

Time frame

Time of surgery

Resection margin positivity rate (proportion of patient with tumor present at resection margin on final histology)

Final histology reports for the resected breast tissue specimen will be reviewed and proportion of patients who have invasive or in-situ breast cancer present at the circumferential resection margin (superior, inferior, medial and lateral) will be calculated. This will be assessed against the accepted departmental standard of 10 - 15%.

Time frame

2 weeks post surgery.

Other outcomes

Operator ease of use / acceptability.

Consultant Radiologist performing the Magtrace injection for bracketing will be asked to rate the ease of the bracketing process with Magtrace injection on a linear 1 (very easy) to 10 (very difficult) scale for every patient.

Time frame

Time of intervention

Procedure cost analysis

The overall cost of the bracketing with Magtrace injection will be calculated based on the standardized cost of consumables, time and slot allocation and compared with the costs of using multiple magnetic seeds and wires. Incremental costs (if any) will be calculated to assess cost effectiveness.

Time frame

Time of intervention.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Faisal Specialist Hospital & Research Center

Lead sponsor

Source ClinicalTrials.gov

Apply now