Evaluation of the Diagnostic Performance of MRI±Biopsy to Optimize Resection of Ductal Carcinoma In Situ (DCIS) Breast Cancer
Condition: Breast Cancer
MeSH terms: Carcinoma; Breast Neoplasms; Carcinoma in Situ; Carcinoma, Ductal; Carcinoma, Intraductal, Noninfiltrating
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): MRI±biopsy
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ductal Carcinoma In Situ (DCIS) breast cancer