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Breast Cancer FemalePhase 2FESTANCT05982496

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

A Phase 2 study testing FES, PET/MRI A and Translational analysis in people with Breast Cancer Female and Lobular Breast Carcinoma, run by Università Vita-Salute San Raffaele at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
FES, PET/MRI A and Translational analysis
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
1 siteItaly
Study dates
9 Jun 2026to 1 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients, age>= 18 yrs, diagnosed with primary or advanced breast cancer
  • LumA or ER-positive Lobular subtypes
  • candidates to surgery as first treatment regardless of cN
  • ER-positive Her2 negative BC with ki67>10%

Who cannot join

  • ER-negative tumors
  • Pregnancy;
  • Contraindication to PET;
  • Contraindication to MRI;
  • Claustrophobia;
  • Allergy to the MR contrast agent;
  • Severe renal insufficiency

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rosa Di Micco, MD contact

+39022643 ext. 4565

dimicco.rosa@hsr.it

Nicole Rotmensz, MSc contact

+39022643 ext. 5650

rotmensz.nicole@hsr.it

Italy1 site, 1 recruiting

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132

    Rosa Di Micco, MD, PhD, +39 26434565, dimicco.rosa@hsr.it

    Nicole Rotmensz, MSc, +390226435650, rotmensz.nicole@hsr.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the detailed description

This is a single-centre prospective cohort study where patients with LumA and ER-positive Lob will be enrolled in 1 cohort undergoing: primary surgery; . Aim : Evaluating the performance of FES PET/MRI in axillary staging compared with axillary surgery. Additionally, biological determinants of tumor heterogeneity will be investigated.

Being tested
FES, PET/MRI A, Translational analysis
Medical subject headings
Carcinoma, Lobular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FESDrug

    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

  • PET/MRI AProcedure or surgery

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

  • Translational analysisGenetic

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

Study groups in NCT05982496
Study groupRoleWhat they receive
Cohort AExperimental* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67>10%
Receives: Drug: FES; Procedure: PET/MRI A; Genetic: Translational analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2023
  2. Study start9 Jun 2026
  3. Primary completion15 Jun 2029 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Cohort A * candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%
Masking
None (open label)
Enrolment
119 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05982496
Sponsor's protocol ID
FESTA
Other IDs
2024-512465-14-00
Acronym
FESTA
Status last verified
Jun 2026
First submitted
5 Jul 2023
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36439301

  • 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.

    PubMed 33389408

  • 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.

    PubMed 22399188

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FES, PET/MRI A and Translational analysis in people with Breast Cancer Female and Lobular Breast Carcinoma, run by Università Vita-Salute San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rosa Di Micco, MD (+39022643 ext. 4565, dimicco.rosa@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity of FES PET/MRI in detecting macrometastatic axillary lymph nodes (time frame: Day 50). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05982496, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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