68-Ga-DOTATATE PET-CT Scan for Diagnosis and Staging of Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT01879657|
Recruitment Status : Unknown
Verified August 2015 by Ebrahim Delpassand, Radio Isotope Therapy of America.
Recruitment status was: Recruiting
First Posted : June 18, 2013
Last Update Posted : August 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Carcinoma||Drug: 68Ga-DOTATATE PET scan||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68-Ga-DOTATATE PET-CT Scan for Diagnosis and Staging of Neuroendocrine Tumors|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||August 2016|
Experimental: 68Ga-DOTATATE PET scans
Will perform 68Ga-DOTATATE PET scans on subjects. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection.
The images from 68Ga-DOTATATE PET/CT will be reported by an experienced nuclear medicine physician who will be unaware of the results of the previous 111Inpenteoctreotide study. Areas of abnormal focal uptake will be documented. These areas of abnormal uptake will be compared with cross-sectional imaging (CT or MRI)to confirm the presence of lesions. The images from 111In- penteoctreotide Scintigraphy will be reported independently by another experienced nuclear medicine physician.
Drug: 68Ga-DOTATATE PET scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.
- Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique [ Time Frame: one year ]We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).
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): NCT01879657
|Contact: Ebrahim S Delpassand, MDemail@example.com|
|Contact: Izabela Tworowska, PhDfirstname.lastname@example.org|
|United States, Texas|
|Radio- Isotope Therapy of America||Recruiting|
|Houston, Texas, United States, 77042|
|Contact: Ebrahim S Delpassand, MD|
|Principal Investigator: Ebrahim S Delpassand, MD|
|Principal Investigator:||Ebrahim Delpassand, MD||Radiomedix, Inc.|