Fluoroestradiol PET/CT Imaging in Detecting Tumor Changes in Patients with Estrogen Receptor Positive Cancer

This clinical trial studies how well F-18 16 alpha-fluoroestradiol positron emission tomography/computed tomography (PET/CT) imaging works in detecting tumor changes in patients with estrogen receptor positive cancer. Diagnostic drugs, such as F-18 16 alpha-fluoroestradiol, may be absorbed by tumor cells with estrogen receptors and bind to them. PET/CT imaging can find how much F-18 16 alpha-fluoroestradiol is present. F-18 16 alpha-fluoroestradiol PET/CT imaging may help monitor changes in estrogen receptors in tumors during treatment.

Inclusion Criteria

Patients with histologic/immunochemical proof of estrogen receptor (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
Eastern Cooperative Oncology Group (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

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01916122.

PRIMARY OBJECTIVE:

I. To allow F-18 16 alpha-fluoroestradiol (FES) PET/CT scanning of patients at Memorial Sloan-Kettering Cancer Center (MSKCC).

OUTLINE:

Patients receive F-18 16 alpha-fluoroestradiol intravenously (IV). Within 60 minutes after injection, patients undergo PET/CT imaging over 60 minutes.

After completion of study treatment, patients are followed up per physician discretion.

Trial PhaseNo phase specified

Trial Typediagnostic

Lead OrganizationMemorial Sloan Kettering Cancer Center

Principal InvestigatorRandy Yeh

Primary ID13-071
Secondary IDsNCI-2016-00984
ClinicalTrials.gov IDNCT01916122

Fluoroestradiol PET/CT Imaging in Detecting Tumor Changes in Patients with Estrogen Receptor Positive Cancer

Inclusion Criteria

Exclusion Criteria

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Fluoroestradiol PET/CT Imaging in Detecting Tumor Changes in Patients with Estrogen Receptor Positive Cancer

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Eligibility Criteria

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Trial Objectives and Outline

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