NCT05982496

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for phase_2

Timeline
40mo left

Started Jun 2026

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jun 2026Dec 2029

First Submitted

Initial submission to the registry

July 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
2.8 years until next milestone

Study Start

First participant enrolled

June 9, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

July 5, 2023

Last Update Submit

June 9, 2026

Conditions

Breast Cancer FemaleLobular Breast CarcinomaPET/MRIAxillary LymphadenopathyLuminal A Breast Cancer

Outcome Measures

Primary Outcomes (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.

    Day 50

Study Arms (1)

Cohort A

EXPERIMENTAL

* Candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%

Drug: FESProcedure: PET/MRI AGenetic: Translational analysis

Interventions

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

Cohort A
PET/MRI APROCEDURE

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

Cohort A
Translational analysisGENETIC

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

Cohort A

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, MI, 20132, Italy

RECRUITING

Related 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.

    PMID: 36439301BACKGROUND

  • 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.

    PMID: 33389408BACKGROUND

  • 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.

    PMID: 22399188BACKGROUND

MeSH Terms

Conditions

Carcinoma, Lobular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Rosa Di Micco, MD

CONTACT

+39022643dimicco.rosa@hsr.it

Nicole Rotmensz, MSc

CONTACT

+39022643rotmensz.nicole@hsr.it

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Cohort A * candidates to surgery as first treatment regardless of cN * ER+ Her2 negative BC with ki67\>10%
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 5, 2023

First Posted

August 8, 2023

Study Start

June 9, 2026

Primary Completion (Estimated)

June 15, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

June 12, 2026

Record last verified: 2026-06

Locations

IT(1)