FDG PET
Conditions
Brief summary
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.
Interventions
DEVICEFDG PET
FDG PET1 before neoadjuvant chemotherapy FDG PET2 after one cycle of neoadjuvant chemotherapy
Sponsors
Centre Georges Francois Leclerc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
France
Outcome results
None listed