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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04897542
• Other study ID #: FirstAHFujian8
• Status: Recruiting
• Phase: Early Phase 1
• Start date: December 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Weibing Miao, MD
• Phone: 86-0591-87981618
• Email: miaoweibing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• Gallium-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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard uptake value (SUV)	Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE scan.	From right after tracer injection to 2-hours post-injection
Secondary	Lesion numbers	Determination of lesion numbers of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE scan.	From right after tracer injection to 2-hours post-injection