18F FES-PET/MRI for Tailoring Treatment of Luminal a and Lobular Breast Cancer (FESTA)

December 4, 2024 updated by: Rosa Di Micco, MD, Università Vita-Salute San Raffaele

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

221

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
  • Candidates to surgery as first treatment regardless of cN
  • ER+ Her2 negative BC with ki67>10%
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.
Genetic: Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Experimental: Cohort B
• ER positive BC treated with induction ET
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
Genetic: Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Procedure: PET/MRI B
Two additional PET/MRI will be performed before and after induction ET.
Experimental: Cohort C
• Candidates to neoadjuvant chemotherapy
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
Genetic: Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Procedure: PET/MRI C
Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.
Experimental: Cohort D
• Metastatic LumA or ER-positive Lob BC, at first diagnosis or in progression
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
Genetic: Translational analysis
Selected cases of heterogeneous tumors on imaging will be also investigated on pathology, imaging, genomic and radiomic levels.
Procedure: PET/MRI D
Two additional PET/MRI will be performed before and after two cycles of systemic therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes
Time Frame: Day 50
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Standard Uptake Value (SUV) of FES in patients undergoing induction Endocrine Treatment (ET)
Time Frame: Day 0 and Day 50
To investigate the potential correlation between Δ(FES SUV) and Δ(Ki-67 as proliferation index) after induction ET in luminal BC.
Day 0 and Day 50

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
FES PET/MRI sensitivity compared to that of standard imaging in patients undergoimg systemic therapy for neoadjuvant purposes or for metastatic disease.
Time Frame: Day 0
Results from FES PET/MRI will be compared with those from standard imaging in terms of sensitivity and number of lesions detected.
Day 0
FES PET/MRI ability to predict tumor response or no response to therapy
Time Frame: Day 180
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Collaborators

IRCCS San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FESTA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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