Gallium-68 NODAGA-JR11 PECT/CT in Neuroendocrine Tumors

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    100
  • sponsor
    First Affiliated Hospital of Fujian Medical University
Updated on 26 July 2021

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.

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.

Details
Condition Neurectoderma, neuroendocrine tumors, Neuroectodermal Tumor, Neuroendocrine Tumor, neuroendocrine tumour
Treatment Gallium-68 NODAGA-JR11
Clinical Study IdentifierNCT04897542
SponsorFirst Affiliated Hospital of Fujian Medical University
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

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: 310^9/L, Hemoglobin
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 mol/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
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