68Ga-DOTATATE PET/CT in Neuroendocrine Tumor
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|ClinicalTrials.gov Identifier: NCT04041882|
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: 68Ga-DOTATATE||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68Ga-DOTATATE PET/CT for Detection and Evaluation of Neuroendocrine Tumor|
|Actual Study Start Date :||April 1, 2014|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||January 30, 2022|
Experimental: 68Ga-DOTATATE PET/CT
Inject 68Ga-DOTATATE and then perform PET/CT scan
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-DOTATATE. Tracer doses of 68Ga-DOTATATE will be used to image lesions of NET PET/CT scan.
- SUVmax [ Time Frame: through study completion, an average of 3 years ]SUVmax of focal lesions are measured on 68Ga-DOTATATE PET/CT. The SUVmax higher than that of the normal liver tissue is defined as positive.
- Diagnostic value [ Time Frame: through study completion, an average of 3 years ]Diagnostic value of 68Ga-DOTATE PET/CT for NET in comparison with 18F-FDG PET/CT
- Diagnostic value in different grades/types of NET [ Time Frame: through study completion, an average of 3 years ]Diagnostic value of 68Ga-DOTATATE PET/CT in ectopic ACTH-secreting tumor, insulinoma, glucagonoma and so on.
- Overall Survival(OS) [ Time Frame: 1 year and 5 years after been diagnosed ]Analysis of OS for patients receiving 68Ga-DOTATATE PET/CT
- Progressive free survival(PFS) [ Time Frame: 1 year and 5 years after been diagnosed ]Analysis of PFS for patients receiving 68Ga-DOTATATE PET/CT
- SSTR expression/Ki67 and SUV [ Time Frame: through study completion, an average of 3 years ]Correlation between SSTR expression/Ki 67 and SUV in PET
- Risk stratification [ Time Frame: through study completion, an average of 3 years ]Analysis of risk factors and OS/PFS
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): NCT04041882
|Contact: Zhaohui Zhu, MD,PhDfirstname.lastname@example.org|
|Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science||Recruiting|
|Contact: Zhaohui Zhu, MD,PhD 86-10-69154196 email@example.com|
|Study Chair:||Zhaohui Zhu, MD,PhD||Peking Union Medical College Hopital, Chinese Academy of Medical Science|