Neuroendocrine Tumors
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGGallium-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.
Sponsors
Peking Union Medical College Hospital
First Affiliated Hospital of Fujian Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* • Written informed consent. * Patients of either gender, aged ≥ 18 years. * Histologically confirmed diagnosis of Metastatic, well-differentiated neuroendocrine tumor. * A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the tumor region within the previous 6 months prior to dosing day is available. * At least 1 measurable lesion based on RECIST v1.1. * Blood test results as follows (White blood cell: ≥ 3\*10\^9/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x10\^9/L, Alanine aminotransferase / Aspartate aminotransferase / Alkaline phosphatase: ≤ 5 times upper limit od normal (ULN), Bilirubin: ≤ 3 times ULN) * Serum creatinine: within normal limits or \< 120 μmol/L for patients aged 60 years or older. * Calculated Glomerular filtration rate (GFR) ≥ 45 mL/min.
Exclusion criteria
* • Known hypersensitivity to Gallium-68, to NODAGA, to JR11, to TATE or to any of the excipients of Gallium-68 NODAGA-JR11 or Gallium-68 DOTATATE. * Presence of active infection at screening or history of serious infection within the previous 6 weeks. * Therapeutic use of any somatostatin analog, including long-acting Sandostatin (within 28 days) and short-acting Sandostatin (within 2 days) prior to study imaging. If a patient is on long-acting Sandostatina, then a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on short-acting Sandostatin, then a wash-out phase of 2 days is required before the injection of the study drug. * Any neuroendocrine tumor-specific treatment between antagonist and agonist scans. * Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study. * Pregnant or breast-feeding women. * Current history of any malignancy other than neuroendocrine tumor; patients with a secondary tumor in remission of \> 5 years can be included. * Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard uptake value (SUV) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion numbers | From right after tracer injection to 2-hours post-injection | Determination of lesion numbers of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE scan. |
Countries
China
Contacts
Primary ContactWeibing Miao, MD
Backup ContactShaobo Yao, MD
Outcome results
None listed