Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 85 of 3200 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04897542
Recruitment Status : Recruiting
First Posted : May 21, 2021
Last Update Posted : May 21, 2021
Sponsor:
Collaborator:
Peking Union Medical College Hospital
Information provided by (Responsible Party):
Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 1, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

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.




Primary Outcome Measures :
  1. Standard uptake value (SUV) [ Time Frame: 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 :
  1. Lesion numbers [ Time Frame: From right after tracer injection to 2-hours post-injection ]
    Determination of lesion numbers of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE scan.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04897542


Contacts
Layout table for location contacts
Contact: Weibing Miao, MD 86-0591-87981618 miaoweibing@126.com
Contact: Shaobo Yao, MD 86-0591-87981619 yaoshaobo008@163.com

Locations
Layout table for location information
China, Fujian
The First Affiliated Hospital of Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350000
Contact: Weibing Miao, MD    059187981618    miaoweibing@126.com   
Contact: Shaobo Yao, MD    059187981619    yaoshaobo008@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Fujian Medical University
Peking Union Medical College Hospital
Layout table for additonal information
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    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue