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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-25

Study Completion Date

2028-03-25

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.

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Detailed Description

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Conditions

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FDG PET

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Experimental Arm

1. Diagnostic
2. PET1 : before the neoadjuvant treatment
3. start neoadjuvant treatment
4. PET2: two weeks after the start of the first course of chemotherapy
5. surgery

Group Type EXPERIMENTAL

FDG PET

Intervention Type DEVICE

FDG PET1 before neoadjuvant chemotherapy FDG PET2 after one cycle of neoadjuvant chemotherapy

Interventions

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FDG PET

FDG PET1 before neoadjuvant chemotherapy FDG PET2 after one cycle of neoadjuvant chemotherapy

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No