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

Sponsor

First Affiliated Hospital of Fujian Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04897542

Collaborator

(none)

100

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroendocrine Tumors	Drug: Gallium-68 NODAGA-JR11	Early Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Dec 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients will undergo a Gallium-68 NODAGA-JR11 PET/CT as well as a Gallium-68 DOTATATE PET/CT 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 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.

Arm

Intervention/Treatment

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

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

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.

Outcome Measures

Primary Outcome Measures

Standard uptake value (SUV) [From right after tracer injection to 2-hours post-injection]
Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE scan.

Secondary Outcome Measures

Lesion numbers [From right after tracer injection to 2-hours post-injection]
Determination of lesion numbers of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE scan.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100000
2	The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian	China	350000

Sponsors and Collaborators

First Affiliated Hospital of Fujian Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weibing Miao, PhD, Director, Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

ClinicalTrials.gov Identifier:

NCT04897542

Other Study ID Numbers:

FirstAHFujian8

First Posted:

May 21, 2021

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neuroendocrine Tumors

Study Results

No Results Posted as of Jul 28, 2022