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Completed

NCT Number: NCT01916122

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluorestradiol (FES)

Drug

PET/CT imaging

Procedure

Primary outcomes

  1. FES PET/CT scanning

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2013
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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