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Trial Title: Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer

NCT ID: NCT05486182

Condition: Metastatic Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Radiopharmaceuticals

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Description: Administration of one dose of 18F FES for PET/CT imaging
Arm group label: Prospective population

Other name: ESTROTEP

Summary: This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC). Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria. After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators. Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Female aged at least 18 years old at the time of enrolment 2. Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%) 3. HER2-negative primary breast cancer (0, 1+, 2+ FISH negative) 4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion 5. Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormone therapy 6. Patient having undergone an FDG PET/CT during follow-up of first-line treatment for metastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seeking the relapse during 2nd line staging (according to the recommendations of the Guide to Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will be respected between the 2 PET/CT scans (FDG/FES). 7. ECOG 0, 1 or 2 8. Life expectancy of at least 12 months 9. Patient registered with a Social Security scheme 10. Patient having signed an informed consent form 11. Patient able to follow the study procedures and fill in the quality of life questionnaires Exclusion Criteria: 1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES) 2. Patients as first-line treatment for metastatic cancer or aftersecond-line treatment for metastatic cancer 3. Person presenting a known allergy to one of the components of EstroTep 4. Patients having been treated with a CDK4/6 inhibitor in combination with an SERM or SERD as first-line metastatic therapy 5. atients suffering from severe or known chronic liver or renal failure 6. Patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of EstroTep, according to the investigator's opinion 7. Woman of childbearing age with no effective means of contraception according to the investigator's opinion 8. Severe intercurrent disease or comorbidity assessed at risk 9. Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CGFL

Address:
City: Dijon
Zip: 21000
Country: France

Status: Recruiting

Contact:
Last name: Alexandre Cochet, Pr

Phone: +33 (0) 3 80 73 75 00

Facility:
Name: CHU Grenoble Alpes

Address:
City: La Tronche
Zip: 38700
Country: France

Status: Recruiting

Contact:
Last name: Loic DJAÏLEB, Dr

Phone: +33 (0)4 76 76 54 55

Contact backup:
Last name: Emmanuelle JACQUET, Dr

Facility:
Name: Centre Léon Bérard

Address:
City: Lyon
Zip: 69008
Country: France

Status: Recruiting

Contact:
Last name: Sandrine Parisse Di-Martino, Dr

Phone: +33 (0)4 78 78 28 28

Contact backup:
Last name: Jean-Yves Blay, Pr

Phone: +33 (0)4 78 78 28 28

Facility:
Name: Institut du Cancer de Montpellier

Address:
City: Montpellier
Zip: 34298
Country: France

Status: Recruiting

Contact:
Last name: Emmanuel Deshayes, Dr

Phone: +33 (0)4 7 61 31 00

Contact backup:
Last name: William Jacot, Dr

Phone: +33 (0)4 7 61 31 00

Facility:
Name: Centre Antoine Lacassagne

Address:
City: Nice
Zip: 06189
Country: France

Status: Recruiting

Contact:
Last name: Olivier Humbert, Pr

Phone: +33 (0)4 92 03 11 14

Contact backup:
Last name: Jean Marc Ferrero, Pr

Phone: +33 (0)4 92 03 11 14

Facility:
Name: Hôpital Tenon

Address:
City: Paris
Zip: 75020
Country: France

Status: Active, not recruiting

Facility:
Name: Institut Curie

Address:
City: Paris
Zip: 75248
Country: France

Status: Recruiting

Contact:
Last name: Audrey Bellesoeur, Dr

Phone: +33 (0)1 56 24 55 00:

Contact backup:
Last name: Nina JEHANNO, DR

Facility:
Name: Institut Curie

Address:
City: Saint-Cloud
Zip: 92210
Country: France

Status: Active, not recruiting

Facility:
Name: Institut Claudius Regaud Centre de Lutte Contre le Cancer

Address:
City: Toulouse
Zip: 31059
Country: France

Status: Recruiting

Contact:
Last name: Thibault Cassou Mounat, Dr

Phone: +33 (0)5 31 15 50 50

Contact backup:
Last name: Florence Dalenc, Dr

Phone: +33 (0)5 31 15 50 50

Start date: February 8, 2022

Completion date: June 2025

Lead sponsor:
Agency: Zionexa
Agency class: Industry

Collaborator:
Agency: GE Healthcare
Agency class: Industry

Collaborator:
Agency: Simbec-Orion Group
Agency class: Industry

Collaborator:
Agency: Keosys
Agency class: Other

Source: Zionexa

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05486182

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