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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01916122
Recruitment Status : Recruiting
First Posted : August 5, 2013
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Fluorestradiol (FES) Procedure: PET/CT Imaging Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status
Study Start Date : August 2013
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Estrogens

Arm Intervention/treatment
Experimental: (FES) PET/CT for Imaging

FES PET/CT studies will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. A bolus of 5 mCi (+/- 10%) of FES PET/CT will be injected intravenously. 60 (+/- 10) minutes following tracer injection, the patient will be positioned on a GE Discovery PET/CT scanner. A low milliampere CT of from the mid skull to mid thigh will be acquired first, 60-80mAs, 120-140kVp, with a 5mm slice thickness while the patient was free breathing. PET will be acquired at 3-5 minutes per bed position using the 3D mode, approximately 6-7 bed positions. FES PET/CT imaging will take less than 60 minutes. Scans will be reconstructed with iterative reconstruction.

If follow-up FES PT/CT scans are performed on a patient, then the same parameters will be used as the initial FES PET/CT scan.

Drug: Fluorestradiol (FES)
Procedure: PET/CT Imaging



Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01916122


Contacts
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Contact: Randy Yeh, MD 212-639-3776
Contact: Komal Jhaveri, MD 646-888-5145

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Randy Yeh, MD    212-639-3776      
Contact: Komal Jhaveri, MD    646-888-5145      
Principal Investigator: Randy Yeh, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Randy Yeh, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01916122    
Other Study ID Numbers: 13-071
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Fluorestradiol (FES)
PET/CT scan
Estrogen Receptor
13-071