"The Efficacy of 'Radioguided Occult Lesion Localization' (ROLL) Versus 'Wire-guided Localization' (WGL) in Breast Conserving Surgery for Non-palpable Breast Cancer: a Randomized Clinical Trial"

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
R. van Hillegersberg, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00539474
First received: October 3, 2007
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

Rationale:

Approximately 25% of breast cancers detected are non palpable. Accordingly, a localization technique is required to help the surgeon to find and remove the cancer. The current technique (wire guided localization [WGL]) is difficult to perform and has a high rate of tumour positive margins in the resected specimen, requiring a second operation. A new approach in the localization and resection of non-palpable malignant breast lesions is 'radio guided occult lesion localization' (ROLL). ROLL was introduced as a possible replacement for WGL at the `European Institute of Oncology' in Milan in 1996. This technique utilizes the intratumourally injected radiotracer, that is generally used for the lymphatic mapping and SNB, to localize the primary tumour guided by the gamma probe. Five studies so far have proven the applicability of this method.

Objective:

To evaluate the efficacy of Radio Occult Lesion Localisation (ROLL) versus Wire guided Localisation (WGL) in breast conserving surgery for non-palpable breast cancer

Study design:

A multicenter, prospective randomized clinical trial. Patients with proven non-palpable breast cancer will be randomized for either ROLL or WGL.

Study population:

316 women with a core biopsy proven non palpable cT1 breast carcinoma that are eligible for a breast conserving treatment and sentinel node biopsy (SNB).

Intervention (if applicable):

Patients in the WGL group will undergo intra tumoural injection of a nuclear radiotracer under stereotactic or ultrasonographic guidance. After scintigraphic imaging, to monitor the migration of the radiotracer, a guide wire will be inserted under stereotactic or ultrasonographic guidance. The excision of the primary tumour is guided by the inserted wire and the sentinel node procedure is performed using a gamma probe and intratumoural injection of patent blue.

Patients in the ROLL group will undergo the same procedure except for the guide wire insertion. The excision of the primary tumour is guided by the gamma probe.

Main study parameters/endpoints:

Primary study endpoints; ROLL vs WGL:

  1. The percentage of tumour-free margins (invasive and in situ)
  2. The volume and maximum diameter of the lumpectomy

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

There is no pre-, per- or post operative extra burden. The radiofarmacon is already used in the standard care of breast cancer patients for the sentinel node biopsy. The used radio-active substance does not damage the patient.

A specific burden questionnaire, aimed at evaluating the burden of the cosmetic result, will be administered. To further assess the net impact in terms of Health Related Quality of Life (HRQoL) also the EQ5D will be obtained at T = 0, 6, 12 and 26 weeks after the initial diagnostic work-up.

Should the results indicate that overall the WGL procedure lead to better clinical outcome a cost-effectiveness analysis is foreseen using bootstrapping to assess the uncertainty with regard to the balance between costs and effects. All analyses will be limited to a half year time horizon. Accordingly, discounting of costs or effects is not applicable.


Condition Intervention Phase
Breast Cancer
Procedure: Radio guided occult lesion localisation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: "The Efficacy of 'Radioguided Occult Lesion Localization' (ROLL) Versus 'Wire-guided Localization' (WGL) in Breast Conserving Surgery for Non-palpable Breast Cancer: a Randomized Clinical Trial"

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Radicality, oncologic outcome [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Doctors questionnaires Patients questionnaire cost-effectiveness analysis [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 316
Study Start Date: January 2008
Study Completion Date: November 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Wireguided localisation
Procedure: Radio guided occult lesion localisation
ROLL procedure using the Europrobe (Europrobe, Strassbourg, France) WGL using a hook wire
Experimental: 2
Radioguided occult lesion localisation
Procedure: Radio guided occult lesion localisation
ROLL procedure using the Europrobe (Europrobe, Strassbourg, France) WGL using a hook wire

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women ≥ 18 years, with a non-palpable breast carcinoma (cT1) that need to be treated with a lumpectomy and sentinel node biopsy

Exclusion Criteria:

  • Pregnant patients or patients who breast feed
  • Patients with multi focal tumour growth
  • Patients with only ductal carcinoma in situ or lobular carcinoma in situ in the core biopsy
  • Patients requiring breast amputation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539474

Locations
Netherlands
Amphia hospital
Breda, Brabant, Netherlands, 4800 RK
st Antonius Hospital
Nieuwegein, Utrecht, Netherlands, 3430 EM
Maasstad Ziekenhuis
Rotterdam, Zuid-Holland, Netherlands, 3078 HT
University Medical Center
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: R van Hillegersberg, dr UMCU
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: R. van Hillegersberg, Professor, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00539474     History of Changes
Other Study ID Numbers: 07/089, ZonMw grant: 80-82310-98-08004
Study First Received: October 3, 2007
Last Updated: December 22, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
ROLL trial
Minimally invasive surgery
Non palpable breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 26, 2014