PET/CT in the Evaluation of Locally Advanced Breast Cancer

Closed for proposals

Project Type

Coordinated Research Project

Project Code

E13044

CRP

2052

Approved Date

9 December 2015

Status

Active - Ongoing

Start Date

19 February 2018

Expected End Date

18 February 2023

Participating Countries

Brazil
India
Japan
Kuwait
Lebanon
Pakistan
South Africa
Thailand
Türkiye
United States of America

Description

Locally advanced breast cancer (LABC) is a leading cause of cancer related morbidity and mortality in many Member States.   In many low-and middle-income countries approximately 45% of patients present with LABC, and  most  of them undergo neoadjuvant chemotherapy (NAC), which is defined as any pharmacological treatment given before primary therapy (surgery), and administered for 4 to 6 months, with an intent to downstage (reduce) the tumour so patients can become candidates for surgery.   Mammography and ultrasound are the diagnostic imaging modalities most commonly used for the initial evaluation of LABC whilst MRI is used to establish the extent of the disease and for the assessment of NAC response.  18F-Fluorodeoxyglucose (18F-FDG) PET/CT is a functional imaging modality, which has shown similar efficacy to MRI in NAC assessment in multiple single centre small studies.  In the last few years a new dedicated breast PET scanner, also known as PEM (positron emission mammography) has emerged as a promising imaging device. This equipment has higher special resolution than the regular PET scanners and lower cost. It can be used for assessment of response to NAC.   There are no multi centric, multinational prospective comparative studies published to establish the efficacy of MRI, versus whole body PET/CT and versus dedicated breast PET. Efficacy is defined as the capacity for beneficial change of a given intervention. This CRP aims to prospectively investigate the diagnostic accuracy of MRI versus whole body PET/CT and dedicated breast PET (PEM) for assessment of response to neoadjuvant chemotherapy in locally advanced breast cancer patients with pathologic response as reference standard. Accurate pathological diagnosis of tumour mass before treatment and careful examination of specimens after treatment are two main objectives in the diagnostic process of neoadjuvant-treated breast cancer. To achieve the first objective, multiple core biopsies can be taken to assess intratumour heterogeneity.                                                                This three-year Coordinated Research Project entitled “Locally Advanced Breast Cancer Neoadjuvant Chemotherapy Assessment: A prospective comparative effectiveness study of MRI versus whole body PET/CT versus dedicated breast PET”  will be conducted by the Section of Nuclear Medicine and Diagnostic Imaging (NMDI) from the Division of Human Health (NAHU).  In order to be able to select the research centres that have the required infrastructure to participate in the above mentioned CRP, a survey that must be completed by centres interested in participating has been developed and should be completed by applicants.

Objectives

To establish the diagnostic accuracy of 18F-FDG whole body PET/CT and the dedicated breast PET (PEM) as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer.

Specific objectives

To establish the prognostic value of 18F-FDG dedicated breast PET; 18F-FDG whole body PET/CT and MRI in the evaluation of response to NAC in patients with LABC for two year progression free or overall survival

To establish the sensitivity and specificity of 18F-FDG whole body PET/CT as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer

To establish the sensitivity and specificity of 18F-FDG dedicated breast PET as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer

Standardization of clinical protocols for breast MRI, 18F-FDG whole-body PET/CT and 18F-FDG dedicated breast PET in participating centres

To establish the prognostic value of 18F-FDG dedicated breast PET; 18F-FDG whole body PET/CT and MRI in the evaluation of response to NAC in patients with LABC for two year progression free or overall survival

To establish the sensitivity and specificity of 18F-FDG whole body PET/CT as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer

To establish the sensitivity and specificity of 18F-FDG dedicated breast PET as compared to MRI for neoadjuvant chemotherapy assessment in locally advanced breast cancer

Standardization of clinical protocols for breast MRI, 18F-FDG whole-body PET/CT and 18F-FDG dedicated breast PET in participating centres

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