Breast PET feasibility study

• Research type

  Research Study

• Full title

  Role of dedicated breast PET in the characterisation of indeterminate breast lesions on MRI requiring a second-look ultrasound - a feasibility study

• IRAS ID

  191866

• Contact name

  Thomas Wagner

• Contact email

  thomas.wagner@nhs.net

• Sponsor organisation

  Royal Free London NHS Foundation Trust

• Duration of Study in the UK

  1 years, 11 months, 31 days

• Research summary

  One of the main uses of breast MRI is in the local staging of breast cancer within a breast already known to contain a biopsy proven malignancy when the breast is dense enough to obscure malignancy. We also use breast MRI in most patients known to have lobular carcinoma as breast MRI is the best method to locally stage in these patients to determine the extent of disease after a recent breast cancer diagnosis.
  
  Lesion size and the presence of additional ipsilateral or contralateral disease are determined. The literature has shown a considerable number of additional mammographically occult cancers found using MRI, particularly with invasive lobular cancers. A disadvantage of MRI is a reported false-positive rate that varies from 8% to 57% according to some authors. These findings lead to unnecessary biopsies that are expensive to perform and anxiety-provoking for patients.

  Abnormalities (such as lobular carcinoma in situ, atypical ductal hyperplasia, and other precancerous lesions) may demonstrate MRI enhancement. To further evaluate indeterminate MRI findings, second-look ultrasound is performed. Since biopsies on MRI are cumbersome to perform, we attempt to identify and biopsy lesions using ultrasound.

  Lesions subjected to MRI guided biopsy after a negative second look ultrasound have a low rate of malignancy.
  
  Breast PET may be able to help in the diagnostic pathway in these patients to determine which ones need to go on to have a second look ultrasound +/- biopsy and those who need to be send for a MRI guided biopsy. This may reduce the need to create more anxiety and uncertainty in this group of patients, already extremely stressed by the recent diagnosis of breast cancer.

  The aim of this study is to determine whether it is feasible to perform a larger study.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  16/LO/0507

• Date of REC Opinion

  15 Jun 2016

• REC opinion

  Further Information Favourable Opinion