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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: FDG PET
• Intervention / Treatment: Device: FDG PET

• Study Type: Interventional
• Enrollment (Estimated): 275
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandrine TIAGO; Email: stiago@cgfl.fr

Study Locations

• France
  • Dijon, France, 21000
    • Emilie REDERSTORFF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Arm; 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; FDG PET1 before neoadjuvant chemotherapy FDG PET2 after one cycle of neoadjuvant chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Centre Georges Francois Leclerc
• Investigators: Principal Investigator: Alexandre COCHET, MD, Centre Feores François Lelcerc

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2015
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): March 25, 2028

Study Registration Dates

• First Submitted: February 13, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (Estimated): March 12, 2015

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2014-A000357-40