Use of Superparamagnetic Iron Oxide (SPIO) in Sentinel Lymph Node Detection for Breast Cancer

May 9, 2023 updated by: MAN Chi Mei Vivian, The University of Hong Kong

Use of Superparamagnetic Iron Oxide (SPIO) Versus Conventional Radioisotope and Patent Blue Dye in Sentinel Lymph Node Detection for Breast Cancer: a Randomized Controlled Trial

Sentinel lymph node biopsy is mandatory during breast cancer operation for disease staging and treatment. The localization of sentinel lymph node is by the injection of radioisotope and blue dye, which is the gold standard. However the use of radioisotope and blue dye are associated with specific drawbacks. Superparamagnetic iron oxide is a magnetic tracer which is FDA-approved for sentinel lymph node localization. The hypothesis of this study is superparamagnetic iron oxide can replace the conventional dual mapping of radioisotope and blue dye in the detection of sentinel lymph nodes for early breast cancers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Sentinel lymph node biopsy has replaced axillary dissection as the standard of care in clinically node negative breast cancer. Lymphatic mapping with radioisotope and blue dye were most studied tracer agents and their combination was shown to give the highest nodal identification rate and lowest false negative rate. However the use of radioisotope is strictly monitored due to its radioactivity and blue dye is associated with potential allergic reactions and skin tattoo. Superparamagnetic iron oxide is non-radioactive. It gives an audible signal with the magnetometer and a brown color as visual cue. It has demonstrated comparable nodal identification rate with the conventional method in multiple non-inferiority trials in Europe and the USA. There was no randomized controlled trial for a head-to-head comparison between these mapping technique. The hypothesis of this study is superparamagnetic iron oxide alone can replace the conventional dual mapping of radioisotope and blue dye.

Previous literature suggested the nodal detection rate for conventional method and SPIO was around 97%. Assuming a non-inferiorly limit of 5%, with a power of 80% and 5% significance level, the number of patients per treatment arm should be 144. We will need a sample size of 300 patients, taking into account a loss to follow-up of <5%.

All patients recruited will be provided full explanation of the study and written voluntary consents will be obtained before randomization.

All data will be prospectively collected by dedicated research assistant and computerized into a database. All statistical analysis will be performed with Statistical Product and Service Solution (SPSS) version 24. Missing information will be marked and significant missing data will be excluded from analysis. Chi-square test will be used to compare discrete variables and student T test or Mann Whitney U test for continuous variables. P value less than 0.05 will be considered statistically significant.

Personal data will be obtained by principal investigator and dedicated research assistant to allow analysis of the results. These data will be anonymous, only identified by the first three letters of patient's name. The file will be encrypted and stored in the study institution. All the information will be solely for research purpose and kept strictly confidential.

Research subjects will be provided with phone contacts for any questions or emergency related to the study.

Study Type

Interventional

Enrollment (Anticipated)

282

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients with clinical T1-3N0 invasive ductal carcinoma or invasive lobular carcinoma planned for breast conservative surgery or mastectomy, with sentinel lymph node biopsy
  • Patients planned for upfront operation or neoadjuvant chemotherapy are allowed

Exclusion Criteria:

  • Patients with hypersensitivity to dextran compounds, iron or blue dye
  • Patients with 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPIO arm
Superparamagnetic iron oxide guided sentinel lymph node mapping
Procedure: sentinel lymph node biopsy procedure
Patient received respective tracer injection and sentinel lymph node biopsy was performed in the operation theatre with the corresponding device.
Active Comparator: Control arm
Conventional radioisotope and blue dye guided sentinel lymph node mapping
Procedure: sentinel lymph node biopsy procedure
Patient received respective tracer injection and sentinel lymph node biopsy was performed in the operation theatre with the corresponding device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sentinel lymph node detection rate per patient
Time Frame: At the time of operation
Successful sentinel lymph node localization for each arm
At the time of operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of sentinel lymph nodes detected
Time Frame: At the time of operation
Number of sentinel lymph nodes detected in each arm
At the time of operation
Duration of sentinel lymph node biopsy
Time Frame: Duration of the operation from incision of axillary fascia to satisfactory nodal basin count
Duration of sentinel lymph node biopsy procedure in each arm
Duration of the operation from incision of axillary fascia to satisfactory nodal basin count
Detection rate of pathologically involved sentinel lymph nodes
Time Frame: At operation
Detection rate of malignant sentinel lymph nodes in each arm
At operation
Duration of skin stain
Time Frame: post-operative 3 month, 6 month, 12 month and 18 month
Duration of blue stain (from blue dye) and brown stain (from SPIO) in respective arm
post-operative 3 month, 6 month, 12 month and 18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Study Director: Ava Kwong, Professor, University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2018

Primary Completion (Anticipated)

February 29, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKUCTR-2709

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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