Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation

NCT03544762 | Unknown Phase 3

• 1 other identifier: 201512142MINA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The propose of this prospective study focuses on the role of \[18F\]FES PET imaging in patients with breast cancer who might receive or are receiving hormone therapy. First, we will develop and optimize the radiosynthesis and quality control tests of \[18F\]FES in conditions that meet good manufacturing practice (GMP) requirements. Secondly, patients with or without metastatic breast cancer will be enrolled for the conduction of human study. \[18F\]FES PET imaging will be performed on patients before the initiation of hormone therapy to predict the prognosis and therapeutic response to hormone therapy. The \[18F\]FES PET results will be compared with ER status obtained by immunohistochemical (IHC) staining on surgically obtained specimens. Moreover, in patients with progression of metastatic disease, the \[18F\]FES PET will be correlated with ESR1 gene mutation, which is one of the mechanisms for resistance to hormone therapy.

Conditions

Breast Cancer

Keywords

breast cancer; PET; [18F]FES; estrogen receptor; hormone treatment; personalized cancer care

Outcome Measures

Primary Outcomes (1)

• PET imaging

  Visual interpretation will be performed first by two independent readers to record if there is any abnormal 18F-FES accumulation. The presence, number, size, character, and location of suspected lesions will be filed for each patient in this study. The final results will be validated by tissue proof, correlation with other imaging, or follow-up results. Semi-quantitative analysis will be performed for each lesion suspected during visual interpretation. Standardized uptake values (SUV) will be obtained by placing regions of interest (ROIs) around the lesions that are identified on visual analysis. The maximum SUV (SUVmax) will be recorded. Volumetric parameters will be performed by placing volume of interests (VOIs) around the suspected lesions. VOIs will be generated using defined fix SUV thresholds or algorithm-generated isocontours. Manual adjustment of VOIs is allowed when non-tumoral tissue is incorrectly included by automatic method.

  in 3 days

Study Arms (1)

18F-FES PET

EXPERIMENTAL

PET/CT

Drug: 18F-FES PET

Interventions

18F-FES PET DRUG

18F-FES PET will be performed for each patient. All patients will receive intravenously injection of 5-8 mCi (185-296 MBq) of 18F-FES. PET imaging will be performed on PET/CT system. The 1-frame dynamic data acquisition of thoracic region including the primary tumor will be started immediately after tracer injection. Whole-body PET acquisition from skull base to upper thigh will be started 60 minutes after tracre injection.

18F-FES PET

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients more than twenty years old
• Patients with breast cancer proven by pathology or cytology
• ER status evaluated by immunohistochemical (IHC) staining; Her2 status evaluated by IHC or in-situ hybridization (ISH)
• Patients will receive hormone therapy as adjuvant therapy or treatment of metastatic disease
• Patients with ESR1 gene analysis
• Life expectancy \>3 months.
• ECOG performance status 0 to 2
• Hematologic Function：
• Neutrophil count ≥1.5×109/L
• Platelet count ≥100×109/L
• Hemoglobin ≥9.0 g/dL
• Liver Function：
• Total bilirubin level ≤ 1.5 mg/dL
• Aspartate transaminase (AST) ≤ 77.5 U/L
• alanine transaminase (ALT) ≤ 102.5 U/L

You may not qualify if:

• Patients with known secondary malignancy other than breast cancer
• Patients not suitable for hormone therapy after clinical assessment
• Patients who received neoadjuvant chemotherapy, radiation or hormone therapy before the operation of newly diagnosed breast cancer
• Patients treated with oral or intravenous cytotoxic agent(s) during the same period of hormone therapy
• Pregnant or planning pregnant woman
• Unclear consciousness
• Allergy to drug
• Cannot accept 18F-FES PET
• Breastfeeding
• There are other tumors
• By doctor evaluation to unsuitable

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 4, 2018
• Study Start: September 8, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 31, 2020
• Last Updated: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)