18F FES-PET/MRI for Tailoring Treatment of Luminal A and Lobular Breast Cancer

Breast Cancer Female Clinical Trial

— FESTA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05982496
• Other study ID #: FESTA
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2024
• Est. completion date: November 1, 2028

Study information

• Verified date: May 2024
• Source: Università Vita-Salute San Raffaele
• Contact: Rosa Di Micco, MD
• Phone: +39022643
• Email: dimicco.rosa[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 221
• Est. completion date: November 1, 2028
• Est. primary completion date: May 15, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Carcinoma, Lobular
• Lobular Breast Carcinoma
• Lymphadenopathy

Intervention

Drug:
• 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

Procedure:
• PET/MRI A
An additional FES PET/MRI will be performed before surgery.
• PET/MRI B
Two additional PET/MRI will be performed before and after induction ET.
• PET/MRI C
Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.
• PET/MRI D
Two additional PET/MRI will be performed before and after two cycles of systemic therapy.

Genetic:
• Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele	Associazione Italiana per la Ricerca sul Cancro, IRCCS San Raffaele

References & Publications (3)

Franquet E, Park H. Molecular imaging in oncology: Common PET/CT radiopharmaceuticals and applications. Eur J Radiol Open. 2022 Nov 24;9:100455. doi: 10.1016/j.ejro.2022.100455. eCollection 2022. — View Citation

Iorfida M, Maiorano E, Orvieto E, Maisonneuve P, Bottiglieri L, Rotmensz N, Montagna E, Dellapasqua S, Veronesi P, Galimberti V, Luini A, Goldhirsch A, Colleoni M, Viale G. Invasive lobular breast cancer: subtypes and outcome. Breast Cancer Res Treat. 2012 Jun;133(2):713-23. doi: 10.1007/s10549-012-2002-z. Epub 2012 Mar 8. — View Citation

Schumacher K, Inciardi M, O'Neil M, Wagner JL, Shah I, Amin AL, Balanoff CR, Larson KE. Is axillary imaging for invasive lobular carcinoma accurate in determining clinical node staging? Breast Cancer Res Treat. 2021 Feb;185(3):567-572. doi: 10.1007/s10549-020-06047-w. Epub 2021 Jan 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	FES PET/MRI sensitivity compared to that of standard imaging in patients undergoimg systemic therapy for neoadjuvant purposes or for metastatic disease.	Results from FES PET/MRI will be compared with those from standard imaging in terms of sensitivity and number of lesions detected.	Day 0
Other	FES PET/MRI ability to predict tumor response or no response to therapy	Results of FES PET/MRI after two cycles of therapy will be compared to final pathology (cohort C) or standard imaging at 6 months (cohort D)	Day 180
Primary	Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes	Ability of FES PET/MRI to detect macrometastatic (tumor deposit>2mm) axillary lymph nodes in BC patients with LumA or Lob who are candidates to primary surgery.	Day 50
Secondary	Changes in Standard Uptake Value (SUV) of FES in patients undergoing induction Endocrine Treatment (ET)	To investigate the potential correlation between ?(FES SUV) and ?(Ki-67 as proliferation index) after induction ET in luminal BC.	Day 0 and Day 50