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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02386709
Other study ID # 2014-A000357-40
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 25, 2015
Est. completion date March 25, 2028

Study information

Verified date February 2024
Source Centre Georges Francois Leclerc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 275
Est. completion date March 25, 2028
Est. primary completion date March 25, 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
FDG PET
FDG PET1 before neoadjuvant chemotherapy FDG PET2 after one cycle of neoadjuvant chemotherapy

Locations

Country Name City State
France Emilie REDERSTORFF Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary difference of ? 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 ? 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 ? SUV (Standardised Uptak Value) threshold at 3 weeks ? SUV threshold at 3 weeks allowing to show the absence of response to treatment
Secondary Progression free survival relation between early metabolic response (difference of ? SUV ) assessed by 18F-FDG PET at 3 weeks and Progression-free survival
Secondary 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)