Localization of Nonpalpable Breast Lesions

• ClinicalTrials.gov Identifier: NCT01901991
• Recruitment Status: Completed
• First Posted: July 17, 2013
• Last Update Posted: August 11, 2017
• Sponsor: Rigshospitalet, Denmark
• Information provided by (Responsible Party): Linnea Langhans, Rigshospitalet, Denmark

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Carcinoma in Situ	Procedure: Radioactive seed localization (RSL); Procedure: Wire-guided localization (WGL)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 410 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Study of Localization of Nonpalpable Breast Lesions - RSL vs WGL
• Study Start Date: January 2014
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: February 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Radioactive seed localization (RSL); 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); Localization of nonpalpable breast lesions with Radioactive seed localization
Active Comparator: Wire-guided localization (WGL); 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); Localization of nonpalpable breast lesions with Wire-guided localization

Outcome Measures

Primary Outcome Measures :

1. Re-operation rate due to positive microscopic margins detected at the final pathological evaluation. [ Time Frame: Re-operation within 3 months after the initial breast conserving surgery. ]

Secondary Outcome Measures :

1. Amount of excised breast tissue in relation to tumour size. [ Time Frame: 3 months. ]

Other Outcome Measures:

1. Duration of the surgical procedure. [ Time Frame: 3 months. ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion criteria:

• 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.

Contacts and Locations

Locations

Denmark

Rigshospitalet (Copenhagen University Hospital)

Copenhagen, Østerbro, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

• Study Chair: Niels Kroman, Professor; Rigshospitalet (Copenhagen University Hospital), Department of Breast Surgery

More Information

Publications of Results:

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.

• Responsible Party: Linnea Langhans, MD, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT01901991
• Other Study ID Numbers: R72-A4701-13-S9
• First Posted: July 17, 2013
• Last Update Posted: August 11, 2017
• Last Verified: September 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data will be presented in a international peer review article.

Keywords provided by Linnea Langhans, Rigshospitalet, Denmark:

Nonpalpable breast lesions; Breast Cancer and carcinoma in situ; Radioactive seed localization; Wire-guided localization; Randomized study

Additional relevant MeSH terms:

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms