[18F]Fluoroestradiol-PET/CT Imaging of Invasive Lobular Carcinoma

NCT04252859 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: HCI128055
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

FES PET/CT imaging for invasive lobular cancer

Conditions

Invasive Lobular Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Positive Detection Rate of Invasive Lobular Carcinoma (ILC)

  The number of known ILC sites that demonstrate abnormal FES uptake by FES-PET/CT, defined as focal uptake above background with standardized uptake value (SUV) max of 1.5 or greater, relative to the total number of known ILC sites.

  At time of baseline FES-PET/CT imaging

• Change in Staging of Patients With Newly Diagnosed ILC

  Blinded analysis was performed to determine staging fore each patient using FES-PET/CT imaging only and compared to the clinical stage assigned to each patient using a standard-of-care evaluation.

  At time of baseline FES-PET/CT imaging

Secondary Outcomes (8)

• Rate of Estrogen Receptor Positive (ER+) ILC That Does Not Demonstrate Positive FES Uptake

  At time of baseline FES-PET/CT imaging

• Rate of Estrogen Receptor Negative (ER-) ILC That Does Demonstrate Positive FES Uptake

  This secondary endpoint was evaluated using data collected during Pilot Phase only.

• Rate of Same-patient (Inter-tumoral) Heterogeneous FES Uptake

  At time of baseline FES-PET/CT imaging

• Rate of Discordant Uptake (FES Positive/FDG Negative or FES Negative/FDG Positive)

  At time of baseline FES-PET/CT imaging and FDG-PET/CT (done within four weeks of FES-PET/CT imaging)

• Correlation of Lesion Uptake Between FES and FDG.

  At time of baseline FES-PET/CT imaging and FDG-PET/CT (done within four weeks of FES-PET/CT imaging)

Study Arms (2)

Pilot Phase

EXPERIMENTAL

Subjects with biopsy-proven invasive lobular carcinoma (ILC), diagnosed within 12 weeks of imaging, confirmed from biopsy of primary tumor or metastasis, will undergo one Fluorine-18 (18F) -Fluoroestradiol (FES) positron emission tomography/computed tomography (PET/CT) scan and one optional 18F-fluorodeoxyglucose (FDG) PET/CT(if a standard of care scan not already performed). For the FES scan, patients are administered a dose of approximately 6 millicurie (mCi) and imaged approximately 60 minutes after injection. For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.

Drug: [18F]Fluoroestradiol (FES) PET/CT

Expansion Phase

EXPERIMENTAL

Subjects with histologically confirmed estrogen receptor positive (ER+) invasive lobular carcinoma (ILC), diagnosed within 16 weeks of imaging, confirmed from biopsy of primary tumor or metastasis, will undergo one 18F-Fluoroestradiol (FES) PET/CT scan, one optional 18F-FDG PET/CT (if a standard of care scan not already performed), and one optional follow-up FES-PET/CT. For the FES scan, patients are administered a dose of approximately 6 mCi and imaged approximately 60 minutes after injection. For the FDG scan, patients are administered a dose of approximately 15 mCi and imaged approximately 60 minutes after injection.

Drug: [18F]Fluoroestradiol (FES) PET/CT

Interventions

[18F]Fluoroestradiol (FES) PET/CT DRUG

\[18F\]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)

Also known as: Fluorine-18 (18F) Fluoroestradiol

Expansion Phase; Pilot Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or greater
• All patients or legal guardians are willing and able to sign a written informed consent and HIPAA authorization in accordance with local and institutional guidelines.
• Histologically confirmed invasive lobular carcinoma within the past 12 weeks confirmed from biopsy of primary tumor or metastasis.
• Patient is willing to have their clinical records reviewed for at least 24 months after enrollment.
• FOR PILOT PHASE COMPLETED IN 2021:

You may not qualify if:

• Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.
• Patients who require monitored anesthesia for PET/CT scanning.
• Patients who are too claustrophobic to undergo PET/CT scanning.
• Pregnancy or current breast feeding.
• Any patient that is medically unstable defined as patient requiring inpatient hospitalization or needing evaluation at an acute care or urgent care facility at time of imaging.
• Patient who have had the site(s) of biopsy proven invasive lobular carcinoma surgically resected.
• FOR EXPANSION PHASE ADDED IN MARCH 2022 AMENDMENT:
• Adults aged 18 years or greater
• All patients or legal guardians are willing and able to sign a written informed consent and HIPAA authorization in accordance with local and institutional guidelines.
• Patient must qualify for one of the following:
• Primary endpoint analysis/Primary Arm:
• Histologically confirmed ER+ invasive lobular carcinoma within the past 16 weeks confirmed from biopsy of primary tumor or metastasis (n=40).
• Exploratory Arm 1:
• Histologically confirmed ER+ invasive lobular carcinoma at any time in the past, confirmed from biopsy of primary tumor or metastasis, with confirmed or imaging suspected metastatic disease, currently on antihormonal therapy or chemotherapy (n=10).
• Exploratory Arm 2:

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• Covington MF, Hoffman JM, Morton KA, Buckway B, Boucher KM, Rosenthal RE, Porretta JM, Brownson KE, Matsen CB, Vaklavas C, Ward JH, Wei M, Buys SS, Chittoria N, Yakish ED, Archibald ZG, Burrell LD, Butterfield RI, Yap JT. Prospective Pilot Study of 18F-Fluoroestradiol PET/CT in Patients With Invasive Lobular Carcinomas. AJR Am J Roentgenol. 2023 Aug;221(2):228-239. doi: 10.2214/AJR.22.28809. Epub 2023 Mar 15.

  PMID: 36919879 DERIVED

MeSH Terms

Conditions

Carcinoma, Lobular

Interventions

proto-oncogene protein c-fes-fps; Fluorine-18

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Sam Mitchell
• Organization: Huntsman Cancer Institute, Center for Quantitative Cancer Imaging

sam.mitchell@hci.utah.edu

801-213-6110

Study Officials

• Jeffrey Yap, PhD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: February 5, 2020
• Study Start: December 11, 2020
• Primary Completion: December 7, 2024
• Study Completion: December 7, 2024
• Last Updated: May 18, 2025
• Results First Posted: May 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)