Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Carcinoma

Recurrence

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

Fluorides

Fluorodeoxyglucose F18

Estrogens

Radiopharmaceuticals

Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

F-18 16 Alpha-Fluoroestradiol

Positron Emission Tomography

Computed Tomography

Fludeoxyglucose F-18

Laboratory Biomarker Analysis

Hannah Linden

This clinical trial studies use of F-18 16 alpha-fluoroestradiol (\[F-18\] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.

OUTLINE:

Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

After completion of study, patients are followed up for up to 20 years.

Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy

Serial [F-18] Fluoroestradiol (FES) PET Imaging to Evaluate Endocrine-targeted Therapy

FES uptake will be quantified using lean body mass adjusted SUV (SUL). Percentage change in FES average SULmax between baseline and a second FES scan will be calculated for up to 3 lesions per patient.

Quantitative measures of FES uptake for each disease site will be determined by drawing regions-of-interest on lesions to determine maximal FES uptake (SUVmax) per lesion. Up to 10 sites seen on the static torso survey will be quantified.

The number of patients showing a 20% increase in FES uptake (SULmean or SUVmax) compared to baseline from the first to second scan using a 90% Wilson score binomial confidence interval.

Time to disease progression will be measured as the time from the start of endocrine therapy to the time the patient is first recorded as having disease progression.

University of Washington

Professor

Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

Diagnostic (F-18 FES PET/CT)

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Hannah Linden, MD

Change in F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV) - Avg SULmax

FES scan 1

FES scan 2

F-18 16 Alpha-fluoroestradiol (FES) Uptake

Proportion of Patients With a Threshold of Percentage Change, or That Surpass a Targeted Follow-up F-18 16 Alpha-fluoroestradiol (FES) Standardized Uptake Value (SUV)

Time to Disease Progression

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy	NCT04692103	Estrogen Recept... Primary or Recu... Stage IV Breast...	F-18 16 Alpha-F... Positron Emissi... Computed Tomogr... Fludeoxyglucose... Positron Emissi... Computed Tomogr... Laboratory Biom...	18 Years -	University of Washington
Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy	NCT04692103	Estrogen Recept... Primary or Recu... Stage IV Breast...	F-18 16 Alpha-F... Positron Emissi... Computed Tomogr... Fludeoxyglucose... Positron Emissi... Computed Tomogr... Laboratory Biom...	18 Years -	University of Washington

Spots Global Cancer Trial Database for primary or recurrent breast carcinoma