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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01916122
• Other study ID #: 13-071
• Status: Completed
• Phase: Early Phase 1
• Start date: August 1, 2013
• Est. completion date: April 3, 2024

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 3, 2024
• Est. primary completion date: April 3, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Fluorestradiol (FES)

Procedure:
• PET/CT Imaging

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FES PET/CT scanning	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.	5 years

External Links

•   Memorial Sloan Kettering Cancer Center