Inflammation and presence of M2 macrophages explorations with[18F]-DPA-714 PET/CT in Triple Negative breast cancers

Phase 1

• Conditions: Patients with Triple Negative Breast Cancer prior to surgical treatment; MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001463-75-FR
• Lead Sponsor: INSTITUT DE CANCEROLOGIE DE L'OUEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-18
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

1. Patient over the age of 18
2. Patient with Triple Negative Breast Cancer defined according to the following criteria:
- Estrogen receptors <10%
- and progesterone receptors <10%
- And HER2 not amplified or not overexpressed
3. Patient with a primary tumor having a primary surgery indication
4. PS 0 or 1
5. Effective contraception in women of childbearing age

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. Patient with non-triple negative breast cancer
2. Patient with inflammatory breast cancer
3. Patient with metastatic breast cancer
4. Patient receiving anti-cancer treatments such as chemotherapy, immunotherapy, biological response modifiers, hormone therapy and radiotherapy BEFORE biopsy and PET examinations
5. Treated diabetes with fasting glucose > 10 mmol / L
6. Patient who received antibiotics and / or steroidal and / or nonsteroidal anti-inflammatory drugs within 30 days BEFORE [18F] - DPA-714 PET/CT
7. Contraindication to performing an MRI (implants or metal prosthesis, severe claustrophobia, pacemaker ...)
8. Contraindication to injection of iodinated contrast media
9. Patient deprived of liberty or placed under the authority of a guardian
10. Pregnant woman, likely to be pregnant or breastfeeding
11. Agitation, impossibility of lying motionless for at least 1 hour, or known claustrophobia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified