Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Chemotherapy in Patients With Mammary Gland Cancer

N/AActive Not RecruitingNCT02386709

Centre Georges Francois Leclerc275 enrolled

Overview

Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate of pCR is about 20%, although there are important variations according to tumor subtype and the type of treatment. The objective of the new therapeutic strategies is to increase this response rate. The purpose of this study is to investigate the possibility of early evaluation of neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

275

Conditions

FDG PET

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient having been informed of the study * patient affiliated to a social health insurance * ≥ 18 years * patient presenting a breast cancer histologically confirmed * indication of neoadjuvant chemotherapy treatment (classification UICC: II or III) * patient agrees with exploitation of his clinical, biological and image data Exclusion Criteria: * distant metastasis * contraindications to chemotherapy * contraindications to surgery * refusal * serious illness not balanced, subjacent infection * pregnancy or breast feeding * diabetes not controlled (glycemia\> 8 mmol/L) * psychiatric disease * patient under supervision, trusteeship or safeguard of justice

Outcomes

Primary Outcomes

difference of Δ SUV (Standardised Uptak Value) between 18F-FDG PET 1 and 18F-FDG PET2 to predict pCR during neoadjuvant chemotherapy

Time frame: early metabolic response mesure by 18F-FDG PET (difference of Δ SUV) at 3 weeks after neoadjuvant chemotherapy to predict pathologic Complete Response (pCR) by exploiting PET data realized before treatment (PET1) and after a cure of chemothrapy (PET2)

Secondary Outcomes

Δ SUV (Standardised Uptak Value) threshold at 3 weeks

Time frame: Δ SUV threshold at 3 weeks allowing to show the absence of response to treatment

Progression free survival

Time frame: relation between early metabolic response (difference of Δ SUV ) assessed by 18F-FDG PET at 3 weeks and Progression-free survival

modification of tumor perfusion by 18F-FDG PET

Time frame: modifications of tumor perfusion befoire and after one cycle(3 weeks) neoadjuvant chemotherapy by exploiting PET/PDG data (PET1 and PET2)