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

Not Applicable

Active, not recruiting

• Conditions: FDG PET
• Interventions: Device: FDG PET

• Registration Number: NCT02386709
• Lead Sponsor: Centre Georges Francois Leclerc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-03-11
• Study First Posted: 2015-03-12
• Study Start: 2015-03-25
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14
• Primary Completion: 2028-03-25
• Study Completion: 2028-03-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 275

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Arm	FDG PET	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Emilie REDERSTORFF; 🇫🇷 Dijon, France