Clinical trial

18F-FES PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer: a Phase II Prospective Cohort Study Evaluating the Performance of FES PET/MRI in Axillary Staging Compared With Axillary Surgery

Name

FESTA

Description

Study hypothesis is that combining the advantages of hybrid PET/MRI and the high sensitivity/specificity of 16-alpha-18F-fluoro-17-beta-estradiol(FES), a radiolabeled form of estrogen binding to functionally active ER, the investigators could obtain a reliable, non-invasive, operator-independent, one-stage imaging method for staging LumA and ER-positive Lobular tumours.

Trial arms

Trial start

2024-10-15

Estimated PCD

2027-05-15

Trial end

2028-11-01

Status

Not yet recruiting

Treatment

FES

16-alpha-18F-fluoro-17-beta-estradiol(FES) is a radiolabeled form of estrogen binding to functionally active ER which will be used as radiotracer for the PET/MRI exam

Arms:

Cohort A, Cohort B, Cohort C, Cohort D

PET/MRI A

An additional FES PET/MRI will be performed before surgery.

Arms:

Cohort A

PET/MRI B

Two additional PET/MRI will be performed before and after induction ET.

Arms:

Cohort B

PET/MRI C

Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.

Arms:

Cohort C

PET/MRI D

Two additional PET/MRI will be performed before and after two cycles of systemic therapy.

Arms:

Cohort D

Translational analysis

Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.

Arms:

Cohort A, Cohort B, Cohort C, Cohort D

Size

221

Primary endpoint

Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes

Day 50

Eligibility criteria

Inclusion Criteria: * Female patients, age\>= 18 yrs, diagnosed with primary or advanced breast cancer * LumA or ER-positive Lobular subtypes Cohort A * candidates to surgery as first treatment regardless of cN * ER-positive Her2 negative BC with ki67\>10% Cohort B * ER positive BC treated with induction ET Cohort C * candidates to neoadjuvant chemotherapy Cohort D * Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression Exclusion Criteria: * ER-negative tumors * Pregnancy; * Contraindication to PET; * Contraindication to MRI; * Claustrophobia; * Allergy to the MR contrast agent; * Severe renal insufficiency

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cohort A\n\n* candidates to surgery as first treatment regardless of cN\n* ER+ Her2 negative BC with ki67\\>10% Cohort B\n* ER positive BC treated with induction ET Cohort C\n* candidates to neoadjuvant chemotherapy Cohort D\n* Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 221, 'type': 'ESTIMATED'}}

Updated at

2024-05-08

1 organization

2 products

5 indications

Organization

Università Vita-Salute San Raffaele

Product

FES

Indication

Breast Cancer

Indication