Gallium-68 NODAGA-JR11 PECT/CT in Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT04897542|
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : July 19, 2021
NODAGA-JR11 is a novel somatostatin receptor antagonist, while Gallium-68 DOTATATE is a typical somatostatin receptor agonist. This study is to evaluate the lesion detection ability of Gallium-68 NODAGA-JR11 for the diagnostic imaging of metastatic, well-differentiated neuroendocrine tumors using positron emission tomography / computed tomography (PET/CT).
The results will be compared between antagonist Gallium-68 NODAGA-JR11 and agonist Gallium-68 DOTATATE in the same group of patients.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Gallium-68 NODAGA-JR11||Early Phase 1|
Patients with histologically confirmed metastatic, well-differentiated neuroendocrine tumors will be recruited in this study.
Each patient received an intravenous injection of 68Ga-DOTATATE (40ug/150-200MBq) on the first day and 68Ga-NODAGA-JR11 (40ug/150-200MBq) on the second day. Whole-body PET/CT scans were performed at 40-60 min after injection on the same scanner. Physiologic normal-organ uptake, lesion numbers, and lesion uptake were compared.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study to Evaluate the Lesion Detection Ability of Gallium-68 NODAGA-JR11 for the Diagnostic Imaging of Metastatic, Well-differentiated Neuroendocrine Tumors Using PET/CT|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||December 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
Experimental: Patients will undergo a Gallium-68 NODAGA-JR11 PET/CT as well as a Gallium-68 DOTATATE PET/CT
Each patient receive a single intravenous injection of Gallium-68 DOTATATE (40ug/150-200MBq) PET/CT, and undergo PET/CT scan at 40-60 min post-injection.
All patients have to do a Gallium-68 NODAGA-JR11 PET/CT scan (40ug/150-200MBq, 40-60 min post-injection) for comparison on the next day of DOTATATE scan.
Drug: Gallium-68 NODAGA-JR11
Each patient receive a single intravenous injection of Gallium-68 NODAGA-JR11 (40ug/150-200MBq) PET/CT, and undergo PET/CT scan at 40-60 min post-injection.
- Standard uptake value (SUV) [ Time Frame: From right after tracer injection to 2-hours post-injection ]Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE scan.
- Lesion numbers [ Time Frame: From right after tracer injection to 2-hours post-injection ]Determination of lesion numbers of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE scan.
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): NCT04897542
|Contact: Weibing Miao, MDfirstname.lastname@example.org|
|Contact: Shaobo Yao, MDemail@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100000|
|Contact: Li Huo, MD 13910801986 firstname.lastname@example.org|
|The First Affiliated Hospital of Fujian Medical University||Recruiting|
|Fuzhou, Fujian, China, 350000|
|Contact: Weibing Miao, MD 059187981618 email@example.com|
|Contact: Shaobo Yao, MD 059187981619 firstname.lastname@example.org|