Fluorestradiol (FES) PET/CT for Imaging Estrogen Receptor Status
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|ClinicalTrials.gov Identifier: NCT01916122|
Recruitment Status : Recruiting
First Posted : August 5, 2013
Last Update Posted : November 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Fluorestradiol (FES) Procedure: PET/CT Imaging||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Contact: Randy Yeh, MD||212-639-3776|
|Contact: Komal Jhaveri, MD||646-888-5145|
|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|
|Principal Investigator:||Randy Yeh, MD||Memorial Sloan Kettering Cancer Center|