Clinical trial NCT02386709: Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Chemotherapy in Patients With Mammary Gland Cancer
Official title: Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Treatment in Patients With Mammary Gland Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: FDG PET
Lead sponsor: Centre Georges Francois Leclerc
Sponsor class: OTHER
First posted: 2015-03-12
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: difference of Δ SUV (Standardised Uptak Value) between 18F-FDG PET 1 and 18F-FDG PET2 to predict pCR during neoadjuvant chemotherapy
timeFrame: 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:
measure: Δ SUV (Standardised Uptak Value) threshold at 3 weeks
timeFrame: Δ SUV threshold at 3 weeks allowing to show the absence of response to treatment
measure: Progression free survival
timeFrame: relation between early metabolic response (difference of Δ SUV ) assessed by 18F-FDG PET at 3 weeks and Progression-free survival
measure: modification of tumor perfusion by 18F-FDG PET
timeFrame: modifications of tumor perfusion befoire and after one cycle(3 weeks) neoadjuvant chemotherapy by exploiting PET/PDG data (PET1 and PET2)
Other outcomes:
Locations:
city: Dijon
country: France
facility: Emilie REDERSTORFF
Study officials:
affiliation: Centre Feores François Lelcerc
name: Alexandre COCHET, MD
role: PRINCIPAL_INVESTIGATOR
References: