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

Study Overview
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Brief Summary
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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.

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

Conditions
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FDG PET

Intervention / Treatment
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* Device: FDG PET


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>Diagnostic PET1 : before the neoadjuvant treatment start neoadjuvant treatment PET2: two weeks after the start of the first course of chemotherapy surgery | Device: FDG PET<br>* FDG PET1 before neoadjuvant chemotherapy FDG PET2 after one cycle of neoadjuvant chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference of Δ SUV (Standardised Uptak Value) between 18F-FDG PET 1 and 18F-FDG PET2 to predict pCR during neoadjuvant chemotherapy |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Δ SUV (Standardised Uptak Value) threshold at 3 weeks |  | Δ SUV threshold at 3 weeks allowing to show the absence of response to treatment | 
| Progression free survival |  | 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 |  | modifications of tumor perfusion befoire and after one cycle(3 weeks) neoadjuvant chemotherapy by exploiting PET/PDG data (PET1 and PET2) |