Clinical trial · Interventional
Gallium-68 NODAGA-JR11 PECT/CT in Neuroendocrine Tumors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gallium-68 NODAGA-JR11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients will undergo a Gallium-68 NODAGA-JR11 PET/CT as well as a Gallium-68 DOTATATE PET/CT
- description
- 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.
- interventionNames
- Drug: Gallium-68 NODAGA-JR11
Primary outcomes (1)
- measure
- Standard uptake value (SUV)
- timeFrame
- From right after tracer injection to 2-hours post-injection
- description
- Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE scan.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available