Clinical trial · Interventional
Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Chemotherapy in Patients With Mammary Gland Cancer
Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Treatment in Patients With Mammary Gland Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| FDG PET | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FDG PET | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Arm
- description
- 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
- interventionNames
- Device: FDG PET
Primary outcomes (1)
- measure
- difference of Δ SUV (Standardised Uptak Value) between 18F-FDG PET 1 and 18F-FDG PET2 to predict pCR during neoadjuvant chemotherapy
- timeFrame
- 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)
- measure
- Δ SUV (Standardised Uptak Value) threshold at 3 weeks
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available