NCT05288686

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
282

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2018

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

5.6 years

First QC Date

March 10, 2022

Last Update Submit

May 9, 2023

Conditions

Breast CancerSentinel Lymph Node

Keywords

superparamagnetic iron oxidesentinel lymph node detection rate

Outcome Measures

Primary Outcomes (1)

  • sentinel lymph node detection rate per patient

    Successful sentinel lymph node localization for each arm

    At the time of operation

Secondary Outcomes (4)

  • Number of sentinel lymph nodes detected

    At the time of operation

  • Duration of sentinel lymph node biopsy

    Duration of the operation from incision of axillary fascia to satisfactory nodal basin count

  • Detection rate of pathologically involved sentinel lymph nodes

    At operation

  • Duration of skin stain

    post-operative 3 month, 6 month, 12 month and 18 month

Study Arms (2)

SPIO arm

EXPERIMENTAL

Superparamagnetic iron oxide guided sentinel lymph node mapping

Procedure: sentinel lymph node biopsy procedure

Control arm

ACTIVE COMPARATOR

Conventional radioisotope and blue dye guided sentinel lymph node mapping

Procedure: sentinel lymph node biopsy procedure

Interventions

sentinel lymph node biopsy procedurePROCEDURE

Patient received respective tracer injection and sentinel lymph node biopsy was performed in the operation theatre with the corresponding device.

Control armSPIO arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (8)

  • Douek M, Klaase J, Monypenny I, Kothari A, Zechmeister K, Brown D, Wyld L, Drew P, Garmo H, Agbaje O, Pankhurst Q, Anninga B, Grootendorst M, Ten Haken B, Hall-Craggs MA, Purushotham A, Pinder S; SentiMAG Trialists Group. Sentinel node biopsy using a magnetic tracer versus standard technique: the SentiMAG Multicentre Trial. Ann Surg Oncol. 2014 Apr;21(4):1237-45. doi: 10.1245/s10434-013-3379-6. Epub 2013 Dec 10.

    PMID: 24322530RESULT

  • Thill M, Kurylcio A, Welter R, van Haasteren V, Grosse B, Berclaz G, Polkowski W, Hauser N. The Central-European SentiMag study: sentinel lymph node biopsy with superparamagnetic iron oxide (SPIO) vs. radioisotope. Breast. 2014 Apr;23(2):175-9. doi: 10.1016/j.breast.2014.01.004. Epub 2014 Jan 29.

    PMID: 24484967RESULT

  • Pinero-Madrona A, Torro-Richart JA, de Leon-Carrillo JM, de Castro-Parga G, Navarro-Cecilia J, Dominguez-Cunchillos F, Roman-Santamaria JM, Fuster-Diana C, Pardo-Garcia R; Grupo de Estudios Senologicos de la Sociedad Espanola de Patologia Mamaria (SESPM). Superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: A comparative non-inferiority study. Eur J Surg Oncol. 2015 Aug;41(8):991-7. doi: 10.1016/j.ejso.2015.04.017. Epub 2015 May 12.

    PMID: 25997792RESULT

  • Rubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan;41(1):46-51. doi: 10.1016/j.ejso.2014.11.006. Epub 2014 Nov 15.

    PMID: 25466980RESULT

  • Houpeau JL, Chauvet MP, Guillemin F, Bendavid-Athias C, Charitansky H, Kramar A, Giard S. Sentinel lymph node identification using superparamagnetic iron oxide particles versus radioisotope: The French Sentimag feasibility trial. J Surg Oncol. 2016 Apr;113(5):501-7. doi: 10.1002/jso.24164. Epub 2016 Jan 12.

    PMID: 26754343RESULT

  • Ghilli M, Carretta E, Di Filippo F, Battaglia C, Fustaino L, Galanou I, Di Filippo S, Rucci P, Fantini MP, Roncella M. The superparamagnetic iron oxide tracer: a valid alternative in sentinel node biopsy for breast cancer treatment. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12385. Epub 2015 Sep 14.

    PMID: 26365441RESULT

  • Karakatsanis A, Christiansen PM, Fischer L, Hedin C, Pistioli L, Sund M, Rasmussen NR, Jornsgard H, Tegnelius D, Eriksson S, Daskalakis K, Warnberg F, Markopoulos CJ, Bergkvist L. The Nordic SentiMag trial: a comparison of super paramagnetic iron oxide (SPIO) nanoparticles versus Tc(99) and patent blue in the detection of sentinel node (SN) in patients with breast cancer and a meta-analysis of earlier studies. Breast Cancer Res Treat. 2016 Jun;157(2):281-294. doi: 10.1007/s10549-016-3809-9. Epub 2016 Apr 27.

    PMID: 27117158RESULT

  • Chiu HY, Man V, Suen D, Kwong A. Skin-Staining From Superparamagnetic Iron Oxide (SPIO) for Sentinel Lymph Node Sampling-Follow-Up Results From a Randomized Trial. World J Surg. 2026 Jan;50(1):21-28. doi: 10.1002/wjs.70173. Epub 2025 Nov 22.

    PMID: 41273311DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ava Kwong, Professor

    university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking is not possible due to the different color of the injected tracer.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Honorary Clinical Assistant Professor

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 21, 2022

Study Start

July 24, 2018

Primary Completion

February 29, 2024

Study Completion

June 30, 2024

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)