NCT01901991

Brief Summary

Each year the Danish mammography-screening programme identifies a large number of patients with small non-palpable breast cancers or precancerous lesions. The majority of these patients are suitable for breast conserving surgery (BCS). The object of BCS is to remove the suspicious lesion completely without removing excess healthy breast tissue. To obtain this accurate lesion localization is essential. Until today the standard procedure in Denmark has been wire guided localization (WGL). Although the method has been utilized for a number of years it has several disadvantages. Often inaccurate lesion localization leads to incomplete lesion removal (positive margin) and subsequently reoperation. It can postpone the additional systemic treatment, offered after the operation. Other disadvantages are poor cosmetic outcome and inconvenient planning for the patient and the departments involved. The wire needs to be placed on the day of the operation, which decreases the flexibility of the procedure. The purpose of this study is to test a new method named radioactive seed localization (RSL). The method uses a small titanium seed containing radioactive iodine. It will be placed in the centre of the lesion, and during the operation, the surgeon can locate it with a handheld gamma probe. The seed can be placed a few days in advance, which means a more flexible course of treatment. The method seems promising with regards to reoperation rates, but it needs further testing. Hypothesis: RSL is a more accurate method, for localization of nonpalpable breast lesions, than WGL. Using RSL obtains, to a great extent, adequate negative margins, resulting in a reduced number of re-operations. The study will be performed as a randomised clinical trial, where the two methods will be compared to each other. The trial will be performed at the department of breast surgery at Rigshospitalet and include patients with nonpalpable breast lesions. Besides reoperation rates, duration of the surgical procedure and the amount of removed breast tissue will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
410

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 14, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 11, 2017

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

July 14, 2013

Last Update Submit

August 9, 2017

Conditions

Breast CancerCarcinoma in Situ

Keywords

Nonpalpable breast lesionsBreast Cancer and carcinoma in situRadioactive seed localizationWire-guided localizationRandomized study

Outcome Measures

Primary Outcomes (1)

  • Re-operation rate due to positive microscopic margins detected at the final pathological evaluation.

    Re-operation within 3 months after the initial breast conserving surgery.

Secondary Outcomes (1)

  • Amount of excised breast tissue in relation to tumour size.

    3 months.

Other Outcomes (1)

  • Duration of the surgical procedure.

    3 months.

Study Arms (2)

Radioactive seed localization (RSL)

EXPERIMENTAL

Patients are randomised for preoperative lesion localization with either radioactive seed localization (RSL) or wire-guided localization (WGL). In this arm 205 patients will have RSL performed. The radioactive seed is introduced through a gauge needle using standard ultrasound guidance. Once guided to the nonpalpable breast lesion, the seed is deployed into the breast tissue by advancing a stilette in the needle. The exact location is confirmed by mammography. The nonpalpable lesion is located during the operation with a handheld gamma probe, identical to the one used for the sentinel node procedure. The surgical specimen is orientated and examined at the Department of Radiology and Pathology in accordance with the existing guidelines of WGL.

Procedure: Radioactive seed localization (RSL)

Wire-guided localization (WGL)

ACTIVE COMPARATOR

Patients are randomised for preoperative lesion localization with either radioactive seed localization (RSL) or wire-guided localization (WGL). In this arm 205 patients will have WGL performed. Guided by ultrasound or mammography a flexible wire is introduced into the breast by the radiologist just before the operation. The tip of the wire must mark the nonpalpable lesion, and correct localization is verified by mammography. The surgeon uses the wire and mammography as a guide during the operation. The surgical specimen is orientated and examined at the Department of Radiology and Pathology in accordance with the existing guidelines of WGL.

Procedure: Wire-guided localization (WGL)

Interventions

Radioactive seed localization (RSL)PROCEDURE

Localization of nonpalpable breast lesions with Radioactive seed localization

Radioactive seed localization (RSL)
Wire-guided localization (WGL)PROCEDURE

Localization of nonpalpable breast lesions with Wire-guided localization

Wire-guided localization (WGL)

Eligibility Criteria

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

You may qualify if:

  • Patients with nonpalpable breast lesions, carcinoma in situ or invasive carcinoma, where preoperative lesion localization is necessary.
  • All age groups, minimum 18 years

You may not qualify if:

  • Patients with benign nonpalpable breast lesions.
  • Patients who are unable to comprehend the information.
  • Patients who are pregnant, breastfeeding or have children \< 3 years.
  • Patients who have lesions, which requires more than two wires or seeds for localization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet (Copenhagen University Hospital)

Copenhagen, Østerbro, 2100, Denmark

Location

Related Publications (1)

  • Langhans L, Tvedskov TF, Klausen TL, Jensen MB, Talman ML, Vejborg I, Benian C, Roslind A, Hermansen J, Oturai PS, Bentzon N, Kroman N. Radioactive Seed Localization or Wire-guided Localization of Nonpalpable Invasive and In Situ Breast Cancer: A Randomized, Multicenter, Open-label Trial. Ann Surg. 2017 Jul;266(1):29-35. doi: 10.1097/SLA.0000000000002101.

    PMID: 28257326RESULT

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma in Situ

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Niels Kroman, Professor

    Rigshospitalet (Copenhagen University Hospital), Department of Breast Surgery

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 14, 2013

First Posted

July 17, 2013

Study Start

January 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 11, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Data will be presented in a international peer review article.

Locations

DK(1)