To hear about similar clinical trials, please enter your email below
Trial Title:
18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer
NCT ID:
NCT05982496
Condition:
Breast Cancer Female
Lobular Breast Carcinoma
PET/MRI
Axillary Lymphadenopathy
Luminal A Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Carcinoma, Lobular
Lymphadenopathy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Cohort A
- candidates to surgery as first treatment regardless of cN
- ER+ 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
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
FES
Description:
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
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Intervention type:
Procedure
Intervention name:
PET/MRI A
Description:
An additional FES PET/MRI will be performed before surgery.
Arm group label:
Cohort A
Intervention type:
Procedure
Intervention name:
PET/MRI B
Description:
Two additional PET/MRI will be performed before and after induction ET.
Arm group label:
Cohort B
Intervention type:
Procedure
Intervention name:
PET/MRI C
Description:
Two additional PET/MRI will be performed before and after two cycles of neoadjuvant
chemotherapy.
Arm group label:
Cohort C
Intervention type:
Procedure
Intervention name:
PET/MRI D
Description:
Two additional PET/MRI will be performed before and after two cycles of systemic therapy.
Arm group label:
Cohort D
Intervention type:
Genetic
Intervention name:
Translational analysis
Description:
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology,
imaging, genomic and radiomic levels.
Arm group label:
Cohort A
Arm group label:
Cohort B
Arm group label:
Cohort C
Arm group label:
Cohort D
Summary:
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.
Detailed description:
This is a single-centre prospective cohort study where patients with LumA and ER-positive
Lob will be enrolled in 4 cohorts undergoing: primary surgery; induction endocrine
therapy; neoadjuvant chemotherapy; systemic therapy for metastatic disease. For the
purpose of the study an additional FES PET/MRI exam will be performed at baseline for
local and systemic staging and a second exam after systemic therapy. Correlations between
FES PET/MRI parameters and pathology, gene expression and FDG PET parameters, when
available, will be investigated. Aim 1: Evaluating the performance of FES PET/MRI in
axillary staging compared with axillary surgery. Aim 2: Evaluating potential correlations
between changes in FES uptake and changes in proliferation index after 3 weeks of
endocrine therapy before surgery. Aim 3: Evaluating the performance of FES PET/MRI in
staging of patients undergoing systemic therapy in comparison with standard imaging.
Additionally, biological determinants of tumor heterogeneity will be investigated.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 15, 2024
Completion date:
November 1, 2028
Lead sponsor:
Agency:
Università Vita-Salute San Raffaele
Agency class:
Other
Collaborator:
Agency:
Associazione Italiana per la Ricerca sul Cancro
Agency class:
Other
Collaborator:
Agency:
IRCCS San Raffaele
Agency class:
Other
Source:
Università Vita-Salute San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05982496
