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

NCT05982496 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2024-12-10

No results posted yet for this study

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.

Conditions

  • Breast Cancer Female
  • Lobular Breast Carcinoma
  • PET/MRI
  • Axillary Lymphadenopathy
  • Luminal a Breast Cancer

Interventions

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.

PROCEDURE

PET/MRI B

Two additional PET/MRI will be performed before and after induction ET.

PROCEDURE

PET/MRI C

Two additional PET/MRI will be performed before and after two cycles of neoadjuvant chemotherapy.

PROCEDURE

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    collaborator OTHER

  • Università Vita-Salute San Raffaele

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-05-15
Completion
2028-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05982496 on ClinicalTrials.gov