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

FDG PET Clinical Trial

— TREN  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02386709
• Other study ID #: 2014-A000357-40
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• FDG PET

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)