Using Gallium-68 NODAGA-JR11 for imaging 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

This study is testing a new imaging agent called Gallium-68 NODAGA-JR11 to see if it can better detect tumors in patients with neuroendocrine cancers compared to a standard imaging agent.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Fujian Medical University (Academic / other)
• Locations: 2 sites (Beijing, Beijing and 1 other locations)
• Trial ID: NCT04897542 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Gallium-68 NODAGA-JR11, a novel somatostatin receptor antagonist, in detecting lesions in patients with metastatic, well-differentiated neuroendocrine tumors. Participants will receive both Gallium-68 DOTATATE and Gallium-68 NODAGA-JR11 injections on consecutive days, followed by whole-body PET/CT scans to assess lesion detection capabilities. The results will compare the performance of the antagonist against the traditional agonist in the same patient group, providing insights into diagnostic imaging improvements.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed metastatic, well-differentiated neuroendocrine tumors.

Not a fit: Patients with known hypersensitivity to the study drugs or those without measurable lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of imaging for neuroendocrine tumors, leading to better diagnosis and treatment planning.

How similar studies have performed: While the use of somatostatin receptor antagonists in imaging is a novel approach, similar studies have shown promise in enhancing diagnostic capabilities for neuroendocrine tumors.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 1 other locations

• Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Weibing Miao, MD

Conditions Neuroendocrine Tumors