Premarking of Axillary Nodes Before Start of Neoadjuvant Chemotherapy Using Magnetic Approach

NCT05625698 | Completed DMC

• 1 other identifier: SUGBG-2021002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy, radiotherapy and chemotherapy. During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit. Historically, all armpit lymph nodes were surgically removed but this approach is associated long term problems of arm swelling. In more recent times, an increasingly more selective approach is used to treat the armpit nodes. In the presence of cancer spreads in the nodes, an axillary clearance surgery is done otherwise, only the first node(s) also called sentinel node(s) that drain fluids from the cancer, is surgically removed. The identification of nodes using the latter approach is helped by injecting a tracer in the breast and via the lymphatic channels, the tracer is then concentrated in the sentinel nodes. Over recent years, neoadjuvant (preoperative) chemotherapy is being increasingly used to treat breast cancers. This treatment approach can lead up to a large of number of complete cancer response. This in turn can cause difficulties in locating the breast cancer / armpit nodes during surgery after the chemotherapy. New developments like superparamagnetic iron oxide nanoparticles (SPIO or MagTrace®) has been used as an alternate liquid tracer to mark sentinel nodes to facilitate armpit surgery. In addition, small magnetic clip called Magseed® has also been developed which can be inserted into the relevant lymph nodes thereby marking their anatomical position to facilitate surgery. Both MagTrace and Magseed can be used to pre-mark the cancer and armpit nodes before the start of neoadjuvant chemotherapy. In theory, premarking armpit nodes using a magnetic approach is associated with better surgical accuracy in the armpit but there is limited supporting data. Therefore, this study aims to investigate the feasibility of premarking armpit nodes, with or without cancer spread, using magtrace and magseed respectively before patients undergo neoadjuvant chemotherapy.

Conditions

Breast Cancer

Keywords

neoadjuvant chemotherapy, sentinel node, axillary clearance

Outcome Measures

Primary Outcomes (2)

• Detection rate of axillary sentinel node after neoadjuvant chemotherapy

  Cohort 1: Patients with clinically node negative axillary nodes who undergo neoadjuatnt chemotherapy- Injected with Magtrace (magnetic non particles) near the breast cancer. Detection rate of SN using magtrace to be compared with there rate using the standard comparator Technetium-99

  Time between injection of magnetic tracer and technetium-99 is between 3-4 months-

• Detection rate of pre-marked metastatic axillary node(s) with magseed after neoadjuvant chemotherapy

  Cohort 2: Patients with clinically node positive axillary nodes who undergo neoadjuatnt chemotherapy- Injected with Magtrace (magnetic non particles) near the breast cancer. Detection rate of SN using magtrace to be compared with there rate using the standard comparator Technetium-99

  Time between magseed insertion of magnetic tracer and surgery will be 3-4 months

Secondary Outcomes (3)

• Concordance rate of axillary Sentinel Node (SN) identified with BOTH MagTrace and Technetium-99 after neoadjuvant chemotherapy

  Time between injection of magnetic tracer and technetium-99 is between 3-4 months-

• Concordance rate of Sentinel Node and non-Sentinel Nodes identified with BOTH magtrace and technetium-99

  Time between injection of magnetic tracer and technetium-99 is between 3-4 months-

• Incidence of serious adverse events (SAEs)

  Through study completion, an average of 1 year

Study Arms (2)

MagTrace only

OTHER

Cohort 1: Clinically node negative patients undergoing neoadjuvant chemotherapy. This cN0-group will receive MagTrace injections before start of neoadjuvant chemotherapy followed standard routine technetium-99 injections after neoadjuvant chemotherapy to facilitate surgery. Nodes containing Magtrace will be detected by finding the magnetic signals using the SentiMag probe. No other interventions during chemotherapy treatments

Drug: MagTrace only

MagTrace and Magseed

OTHER

Cohort 2: Clinically node positive patients undergoing neoadjuvant chemotherapy. This N+ group will receive MagTrace injection in the breast to mark sentinel nodes and Magseed will be inserted into the index metastatic node before the start of neoadjuatnt chemotherapy followed by standard routine technetium-99 injections after neoadjuvant chemotherapy to facilitate surgery. Nodes containing Magtrace / Magseed will be detected by finding the magnetic signals using the SentiMag probe. No other interventions during chemotherapy treatments

Combination Product: MagTrace and Magseed

Interventions

MagTrace only DRUG

see information in arm descriptions

Also known as: SPIO

MagTrace only

MagTrace and Magseed COMBINATION_PRODUCT

see information in arm descriptions

Also known as: SPIO

MagTrace and Magseed

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A patient meeting the following criteria is eligible for participation in the study:
• Patients 18 years of age or older
• Patients with breast cancer planned to undergo preoperative chemotherapy (NACT) with a) planned sentinel lymph node biopsy (SNB) or b) axillary lymph node dissection, in conjunction with the beast surgery after NACT

You may not qualify if:

• Intolerance / hypersensitivity to iron or dextran compounds or SPIO.
• Patients who are required to undergo MR to evaluate tumour response
• Pregnancy or breast feeding
• Patients with an iron overload disease.
• Patient deprived of liberty or under guardianship.
• Inability to understand given information, give informed consent, undergo study procedures
• MRI (subgroup of patients): Conditions contraindicating MRI including, but not limited to, BMI \> 40 kg/m2, claustrophobia, metallic implants or internal electrical devices (e.g. Pacemaker).

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Uppsala University Hospital: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (7)

• Fisher CS, Margenthaler JA, Hunt KK, Schwartz T. The Landmark Series: Axillary Management in Breast Cancer. Ann Surg Oncol. 2020 Mar;27(3):724-729. doi: 10.1245/s10434-019-08154-5. Epub 2019 Dec 20.

  PMID: 31863417 BACKGROUND

• Racz JM, Caudle AS. Sentinel Node Lymph Node Surgery After Neoadjuvant Therapy: Principles and Techniques. Ann Surg Oncol. 2019 Oct;26(10):3040-3045. doi: 10.1245/s10434-019-07591-6. Epub 2019 Jul 24.

  PMID: 31342394 BACKGROUND

• Samiei S, van Kaathoven BN, Boersma L, Granzier RWY, Siesling S, Engelen SME, de Munck L, van Kuijk SMJ, van der Hulst RRJW, Lobbes MBI, Smidt ML, van Nijnatten TJA. Risk of Positive Sentinel Lymph Node After Neoadjuvant Systemic Therapy in Clinically Node-Negative Breast Cancer: Implications for Postmastectomy Radiation Therapy and Immediate Breast Reconstruction. Ann Surg Oncol. 2019 Nov;26(12):3902-3909. doi: 10.1245/s10434-019-07643-x. Epub 2019 Jul 29.

  PMID: 31359276 BACKGROUND

• Warnberg F, Stigberg E, Obondo C, Olofsson H, Abdsaleh S, Warnberg M, Karakatsanis A. Long-Term Outcome After Retro-Areolar Versus Peri-Tumoral Injection of Superparamagnetic Iron Oxide Nanoparticles (SPIO) for Sentinel Lymph Node Detection in Breast Cancer Surgery. Ann Surg Oncol. 2019 May;26(5):1247-1253. doi: 10.1245/s10434-019-07239-5. Epub 2019 Mar 4.

  PMID: 30830536 BACKGROUND

• Karakatsanis A, Hersi AF, Pistiolis L, Olofsson Bagge R, Lykoudis PM, Eriksson S, Warnberg F; SentiNot Trialists Group. Effect of preoperative injection of superparamagnetic iron oxide particles on rates of sentinel lymph node dissection in women undergoing surgery for ductal carcinoma in situ (SentiNot study). Br J Surg. 2019 May;106(6):720-728. doi: 10.1002/bjs.11110. Epub 2019 Mar 6.

  PMID: 30839104 BACKGROUND

• Brown AS, Hunt KK, Shen J, Huo L, Babiera GV, Ross MI, Meric-Bernstam F, Feig BW, Kuerer HM, Boughey JC, Ching CD, Gilcrease MZ. Histologic changes associated with false-negative sentinel lymph nodes after preoperative chemotherapy in patients with confirmed lymph node-positive breast cancer before treatment. Cancer. 2010 Jun 15;116(12):2878-83. doi: 10.1002/cncr.25066.

  PMID: 20564394 BACKGROUND

• Greenwood HI, Wong JM, Mukhtar RA, Alvarado MD, Price ER. Feasibility of Magnetic Seeds for Preoperative Localization of Axillary Lymph Nodes in Breast Cancer Treatment. AJR Am J Roentgenol. 2019 Oct;213(4):953-957. doi: 10.2214/AJR.19.21378. Epub 2019 Jun 5.

  PMID: 31166765 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ferric oxide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fedrik Warnberg, MD PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a feasibility study

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: October 1, 2021
• Primary Completion: October 28, 2023
• Study Completion: November 28, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)