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

NCT02386709 | Active Not Recruiting

• 1 other identifier: 2014-A000357-40
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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.

Conditions

FDG PET

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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

Device: FDG PET

Interventions

FDG PET DEVICE

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

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Georges Francois Leclerc: lead

Study Sites (1)

Emilie REDERSTORFF

Dijon, 21000, France

Location

Study Officials

• Alexandre COCHET, MD

  Centre Feores François Lelcerc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: March 12, 2015
• Study Start: March 25, 2015
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): March 25, 2028
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

FR (1)