Diagnostic Performance of [18F]FES PET/CT for Axillary LN Metastasis in Invasive Lobular Carcinoma

NCT05960201 | Completed Phase 2

• 1 other identifier: FES lobular
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the diagnostic validity of \[18F\]FES PET/CT for the evaluation of axillary lymph node metastasis in patients with invasive lobular breast cancer having clinically suspected or confirmed axillary lymph node metastasis.

Conditions

Carcinoma, Lobular

Outcome Measures

Primary Outcomes (1)

• Patient based sensitivity, specificity, positive predictive and negative predictive values of a qualitative [18F]FES PET/CT assessment of axillary lymph node metastasis

  diagnostic accuracy of qualitative \[18F\]FES PET/CT analysis

  90-120 min

Secondary Outcomes (4)

• Patient based sensitivity, specificity, positive predictive and negative predictive values of quantitative [ 18 F]FES PET/CT evaluation for axillary lymph node metastasis

  90-120 min

• Patient based sensitivity, specificity, positive predictive and negative predictive values of [18F]FES PET/CT in FNA or CNB-negative patients

  90-120 min

• Detection rate of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastasis

  90-120 min

• Detection rate of qualitative [18F]FES PET/CT evaluation for distant metastasis

  90-120 min

Study Arms (1)

invasive lobular breast cancer

EXPERIMENTAL

images for 90 minutes after F-18 FES injection

Drug: [18F]fluoroestradiol (FES)

Interventions

[18F]fluoroestradiol (FES) DRUG

F-18 FES 111\~222 MBq(megabecquerel) injection

invasive lobular breast cancer

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 19 years or older regardless of race/ethnicity.
• Subjects with histologically confirmed estrogen receptor-positive invasive lobular breast cancer within 90 days prior to \[18F\]FES PET/CT imaging
• Subjects whose primary tumor of cT1-3 according to the American Joint Committee on Cancer (AJCC) 8th tumor staging system
• Subjects with suspected or confirmed axillary lymph node metastasis clinically or in imaging test (ultrasound)
• Subjects who scheduled to undergo sentinel node biopsy or axillay lymph node dissection within 90 days of \[18F\]FES PET/CT imaging
• Subjects whose Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 points or less

You may not qualify if:

• Subject or the subject's legally acceptable representative does not provide written informed consent form
• Subjects with confirmed or suspected large, bulky, matted cN2 or cN3 axillary lymph node metastases, or distant metastases.
• Previous history of ipsilateral axillary lymph node dissection, sentinel lymph node surgery, or lymph node dissection biopsy.
• Patients who are scheduled for or have undergone chemotherapy, radiotherapy, antihormone therapy, targeted therapy, or immunotherapy between \[18F\]FES PET/CT and pathological diagnosis
• Subject has concurrent severe and/or uncontrolled and/or unstable medical condition other than cancer (e.g., congestive heart failure, acute myocardial infarction, severe lung disease, chronic kidney disease or chronic liver disease).
• Subject is a relative or student of the investigator or otherwise in a dependent relationship
• Subject has already participated in this study
• Subject not being able to provide intact data for this study due to personal circumstances or other reasons in the judgment of the investigator

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Lobular

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

Study Officials

• Sangwon Han

  Clinical assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: July 25, 2023
• Study Start: August 10, 2023
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)