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

NCT04897542 | Unknown Early Phase 1

• 1 other identifier: FirstAHFujian8
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lesion numbers

  From right after tracer injection to 2-hours post-injection

Study Arms (1)

Patients will undergo a Gallium-68 NODAGA-JR11 PET/CT as well as a Gallium-68 DOTATATE PET/CT

EXPERIMENTAL

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.

Drug: Gallium-68 NODAGA-JR11

Interventions

Gallium-68 NODAGA-JR11 DRUG

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.

Patients will undergo a Gallium-68 NODAGA-JR11 PET/CT as well as a Gallium-68 DOTATATE PET/CT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (2)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Central Study Contacts

Weibing Miao, MD

CONTACT

86-0591-87981618; miaoweibing@126.com

Shaobo Yao, MD

CONTACT

86-0591-87981619; yaoshaobo008@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Nuclear Medicine

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)