"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"

NCT00539474 | Completed Phase 3 DMC

• 2 other identifiers: 07/089ZonMw grant: 80-82310-98-08004
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Breast Cancer

Keywords

ROLL trial; Minimally invasive surgery; Non palpable breast cancer

Outcome Measures

Primary Outcomes (1)

• Radicality, oncologic outcome

  3 years

Secondary Outcomes (1)

• Doctors questionnaires Patients questionnaire cost-effectiveness analysis

  24 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Wireguided localisation

Procedure: Radio guided occult lesion localisation

2

EXPERIMENTAL

Radioguided occult lesion localisation

Procedure: Radio guided occult lesion localisation

Interventions

Radio guided occult lesion localisation PROCEDURE

ROLL procedure using the Europrobe (Europrobe, Strassbourg, France) WGL using a hook wire

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (4)

Amphia hospital

Breda, North Brabant, 4800 RK, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, South Holland, 3078 HT, Netherlands

Location

st Antonius Hospital

Nieuwegein, Utrecht, 3430 EM, Netherlands

Location

University Medical Center

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (3)

• Postma EL, Koffijberg H, Verkooijen HM, Witkamp AJ, van den Bosch MA, van Hillegersberg R. Cost-effectiveness of radioguided occult lesion localization (ROLL) versus wire-guided localization (WGL) in breast conserving surgery for nonpalpable breast cancer: results from a randomized controlled multicenter trial. Ann Surg Oncol. 2013 Jul;20(7):2219-26. doi: 10.1245/s10434-013-2888-7. Epub 2013 Feb 23.

  PMID: 23435568 DERIVED

• Postma EL, Verkooijen HM, van Esser S, Hobbelink MG, van der Schelling GP, Koelemij R, Witkamp AJ, Contant C, van Diest PJ, Willems SM, Borel Rinkes IH, van den Bosch MA, Mali WP, van Hillegersberg R; ROLL study group. Efficacy of 'radioguided occult lesion localisation' (ROLL) versus 'wire-guided localisation' (WGL) in breast conserving surgery for non-palpable breast cancer: a randomised controlled multicentre trial. Breast Cancer Res Treat. 2012 Nov;136(2):469-78. doi: 10.1007/s10549-012-2225-z. Epub 2012 Sep 30.

  PMID: 23053639 DERIVED

• van Esser S, Hobbelink MG, Peeters PH, Buskens E, van der Ploeg IM, Mali WP, Rinkes IH, van Hillegersberg R. The efficacy of 'radio guided occult lesion localization' (ROLL) versus 'wire-guided localization' (WGL) in breast conserving surgery for non-palpable breast cancer: a randomized clinical trial - ROLL study. BMC Surg. 2008 May 21;8:9. doi: 10.1186/1471-2482-8-9.

  PMID: 18495027 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• R van Hillegersberg, dr

  UMCU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 4, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2011
• Last Updated: December 23, 2011

Record last verified: 2011-12

Locations

NL (4)