Health TrialsbyHealthPanel

[18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer

ConditionStage III Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center

About this trial

This study aims to evaluate the detection rate of distant metastases using \[18F\]FES PET/CT in patients with low-grade, ER-positive stage III breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patients aged ≥19 years, regardless of race/ethnicity

Patients newly diagnosed with invasive breast cancer within 90 days prior to screening, with documented histopathological confirmation.

Patients diagnosed with histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer

Patients with clinical stage IIIA-IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system

Disqualifiers

The subject or the subject's legally authorized representative has not signed the informed consent form

Subjects who are currently receiving systemic therapy for breast cancer (e.g., neoadjuvant chemotherapy, hormonal therapy)

Subjects with a history of another invasive malignancy within the past 2 years (except for non-melanoma skin cancer)

Subjects diagnosed with distant metastases on chest CT, abdominal CT, or bone scintigraphy performed within 90 days prior to screening or before the 18F-FES PET/CT scan

Trial design

Design model

Single group

Treatments tested in this trial

  • Fluoroestradiol (18F)

    Diagnostic test

    Images for 90 minutes after F-18 FES injection

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: [18F]FES PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Patient based detection rate of qualitative [18F]FES PET/CT evaluation for distant metastases

Time frame
Baseline (index [18F]FES PET/CT image interpretation performed within 1 week after PET/CT acquisition, prior to initiation of definitive treatment)

Secondary outcomes

1

Patient-based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for distant metastases

Time frame
From baseline [18F]FES PET/CT to confirmation of reference standard, assessed up to 6 months (histopathologic confirmation or clinical and imaging follow-up ≥6 months, through multidisciplinary consensus review)
2

Patient-based detection rate of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastases

Time frame
Baseline (index [18F]FES PET/CT image interpretation performed within 1 week after PET/CT acquisition, prior to initiation of definitive treatment)
3

Patient-based sensitivity and specificity of qualitative [18F]FES PET/CT evaluation for cN3 lymph node metastases

Time frame
From baseline [18F]FES PET/CT to confirmation of reference standard, assessed up to 6 months (histopathologic confirmation or clinical and imaging follow-up ≥6 months, through multidisciplinary consensus review)
4

Patient-based change rate in clinical management based on qualitative 18F-FES PET/CT evaluation

Time frame
From baseline clinical management plan (pre-[18F]FES PET/CT) to final treatment decision after [18F]FES PET/CT, assessed within 4 weeks after PET/CT

Other outcomes

1

Correlation between qualitative/quantitative [18F]FES PET/CT evaluation and response to neoadjuvant chemotherapy

Time frame
From baseline [18F]FES PET/CT to post-surgical pathologic response assessment after completion of neoadjuvant chemotherapy, assessed up to 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now