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
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Updated on 4 October 2022
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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 Neuroendocrine Tumors
Treatment Gallium-68 NODAGA-JR11
Clinical Study IdentifierNCT04897542
SponsorFirst Affiliated Hospital of Fujian Medical University
Last Modified on4 October 2022

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
≥ 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
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