Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer (IRCIS)

January 25, 2016 updated by: Gustave Roussy, Cancer Campus, Grand Paris
The purpose of this study is to evaluate the diagnostic performance of MRI±biopsy to optimize resection of Ductal Carcinoma In Situ (DCIS) breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ductal carcinoma in situ (DCIS) is a frequent disease, concerning more than 15% of all breast carcinomas in France. Frequency increases due to breast screening programs. Breast conservative treatment can be done for limited lesions. Complete pathological excision with safe surgical margins is the main factor of success rate for conservative treatment. But safe surgical margins are not always obtained in the first surgery because preoperative or peroperative evaluation of the extent of the lesions is difficult. A 20 to 38% rate of involved margins is reported in the literature, implying a second surgery. MRI is not commonly performed today in the preoperative staging of DCIS, despite interesting results of breast MRI in DCIS evaluation published recently in a German study (Kuhl, Lancet 2007). Nevertheless, this retrospective study focused on a population of high-risk women (BRCA1-2 mutation carriers, family history of breast cancer…).

Additional suspicious lesions detected by MRI require MRI-guided or CT-guided biopsy as they are not detectable with mammography or ultrasound. Moreover, intraoperative pathological analysis cannot be performed in DCIS and surgical strategy will be different for a unique lesion (lumpectomy) or multiple/large lesions (mastectomy). If surgery is adapted according to MRI and biopsy results, we can assume that the entire lesion could be removed in a single operation, avoiding re-excisions, anxiety and reducing the costs.

The main objective of this protocol is to evaluate the value of MRI+biopsy in the staging of mammography-detected DCIS in an unselected population of women. It is a multicentric, randomised study including patients from France presenting a unique, limited (< 30 mm) DCIS detected by mammography or breast ultrasound. The two compared arms are: preoperative breast MRI+biopsy versus no additional diagnostic examination. High resolution dynamic 3D images will be obtained in order to detect very small suspicious lesions, typical of DCIS. The main endpoint is the re-excision rate for involved margins. In order to show a reduction of 50% of the rate of second surgery (from 25% to 12.5% in the MRI arm), it is necessary to include 360 patients (bilateral test, alpha=5%, power=80%).

A cost-effective study will be performed. The costs likely to differ between the two arms (MRI, biopsy, outpatient visits, hospitalisations, transportation, and sick leaves) will be assessed using data collected in the trial. The endpoint of the cost-effectiveness study will be the cost by success (cost-effectiveness ratio). A success is defined as achieving margin-negative resection after initial surgery (no need for re-excision). The other secondary endpoints will be to determine the rate of initial mastectomy and to describe MRI morphologic features in the MRI+biopsy arm.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • T0 or T1 breast DCIS revealed by microcalcifications on mammography + breast ultrasound
  • Histological confirmation by percutaneous biopsy : strict DCIS or micro-invasive.
  • Radiological focus < 30mm and accessible to conservative treatment.
  • Single microcalcification focus
  • Age : 18 to 80 years old
  • Performance Status < 2
  • Patient information and signed informed consent.

Exclusion Criteria:

  • Invasive carcinoma
  • Non biopsiable microcalcification focus under stereotaxy
  • Bilateral lesions
  • Non feasible MRI (claustrophobic, serious allergy, pace-maker, etc.)
  • Refusal of surgery, including mastectomy if necessary
  • History of homolateral breast cancer
  • patient at risk of breast cancer (BRCA1 or 2 mutation or score 5 INSERM table)
  • Pregnant or possibly pregnant or breastfeeding woman
  • Person deprived of freedom or under guardianship
  • Inability to undergo the medical surveillance of the trial for geographical, social or psychological reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI±biopsy
a MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm from the initial lesion), not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI ± biopsy results.
Procedure: MRI±biopsy
A MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm for from the initial lesion), which is not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI +/- ± biopsy results.
No Intervention: Standard care
The patients will be operated without additional exams

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-excision rate
Time Frame: in the 6 months following randomization
After histological confirmation of DCIS by stereotactic biopsy the patients will be randomized. In arm 1, a MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm from the initial lesion), not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI ± biopsy results. The patients will be operated without additional exams in arm 2.
in the 6 months following randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness study
Time Frame: during the 6-month period after randomization
cost by success, success being defined by the absence of re-excision during the 6-month period after randomization.
during the 6-month period after randomization
Relapse rate
Time Frame: at 30 months after randomization
at 30 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

National Cancer Institute, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 26, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 25, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGR IRCIS 1503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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