Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01916122

Enrollment

Registered

2013-08-05

Start date

2013-08-01

Completion date

2024-04-03

Last updated

2024-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Fluorestradiol (FES), PET/CT scan, Estrogen Receptor, 13-071

Brief summary

These are tumors which expresses estrogen receptors. Estrogen receptors are found within breast cancer cells and are an important marker of which medicines may best treat a breast cancer. This study is being performed to imaging the amount of estrogen receptors expressed in the tumor. A research agent named 16α-18F-fluoroestradiol (FES) finds estrogen receptors and binds to them. Then tumors with estrogen receptors can be imaged by a PET/CT scanner, a machine that can take pictures of where the FES is and how much FES is present. The results of this study may help researchers know whether FES can be used to monitor changes in estrogen receptors in tumors during treatment.

Interventions

DRUGFluorestradiol (FES)

PROCEDUREPET/CT Imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with histologic/immunochemical proof of ER+ primary or metastatic malignancy (positive staining in ≥ 1% of cells by immunohistochemistry). * Patients who are to be treated with clinically approved or experimental regimens where ER has an important role * ECOG performance status of 0-2. * Patients must provide written informed consent

Exclusion criteria

* Age \<18 years * Patients who cannot undergo PET/CT scanning (i.e. because of weight limits, claustrophobia) * Pregnancy or lactation * Total serum bilirubin \> 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion). Increased serum bilirubin due to Gilbert's syndrome is permitted. * Serum creatinine \> 1.5 times upper limit of normal.

Design outcomes

Primary

Measure	Time frame	Description
FES PET/CT scanning	5 years	The objective of this study is only to allow FES PET/CT scanning of patients at MSKCC. This protocol is an umbrella protocol to allow FES PET/CT scanning to be used in other companion protocols.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026