Localization of Nonpalpable Breast Lesions

NCT ID: NCT01901991

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-02-29

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.

Conditions

Breast Cancer; Carcinoma in Situ

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Radioactive seed localization (RSL)

Intervention Type: PROCEDURE

Localization of nonpalpable breast lesions with Radioactive seed localization

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.

Group Type: ACTIVE_COMPARATOR

Wire-guided localization (WGL)

Intervention Type: PROCEDURE

Localization of nonpalpable breast lesions with Wire-guided localization

Interventions

Radioactive seed localization (RSL)

Localization of nonpalpable breast lesions with Radioactive seed localization

Intervention Type: PROCEDURE

Wire-guided localization (WGL)

Localization of nonpalpable breast lesions with Wire-guided localization

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Linnea Langhans

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niels Kroman, Professor

Role: STUDY_CHAIR

Rigshospitalet (Copenhagen University Hospital), Department of Breast Surgery

Locations

Rigshospitalet (Copenhagen University Hospital)

Copenhagen, Østerbro, Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 28257326 (View on PubMed)

Other Identifiers

R72-A4701-13-S9

Identifier Type: -

Identifier Source: org_study_id