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68Ga-DOTATATE PET/CT in Neuroendocrine Tumor

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ClinicalTrials.gov Identifier: NCT04041882
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
Somatostatin receptor(SSTR) was expressed in neuroendocrine tumor cells and SSTR-targeting molecular imaging(68Ga-DOTATATE PET/CT) could be a promising technique to evaluate the primary tumor and metastatic lesions of neuroendocrine tumors with higher accuracy. This prospective study is going to investigate whether radiolabeled somatostatin analogs 68Ga-DOTATATE PET/CT may be valuable for diagnosis, risk stratification, and prognostic evaluation of neuroendocrine tumors and compared it with 18F-FDG PET/CT.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: 68Ga-DOTATATE Early Phase 1

Detailed Description:
Neuroendocrine tumor(NET)can be derived from endocrine glands, endocrine tissues and endocrine cells from any parts of body. Due to its occult onset and heterogeneity, it is hard to be detected by conventional imaging like CT and it is often at late stage when diagnosed. New imaging modality such as 18F-FDG PET/CT have been well-accepted as a practical way to evaluate the aggressive of tumor. 18F-FDG PET/CT has been used to improve the efficacy in assessing the extent and severity of NET, but the diagnostic accuracy of 18F-FDG PET/CT decreased in low proliferation tumor cells and inflammation. Recent studies showed somatostatin receptor (SSTR) was expressed in NET cells and SSTR-targeting molecular imaging-68Ga-DOTATATE PET/CT could be a promising technique to evaluate the extent of NET with higher accuracy. Especially in some well differentiated tumor, 18F-FDG PET/CT can be negative, while 68Ga-DOTATATE PET/CT can be positive. However, the results can be varied in these two imaging modalities and characterized this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome.This prospective study is going to investigate whether 68Ga-DOTATATE PET/CT may be superior to 18F-FDG PET/CT for diagnosis, risk stratification, and prognostic evaluation of NET.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-DOTATATE PET/CT for Detection and Evaluation of Neuroendocrine Tumor
Actual Study Start Date : April 1, 2014
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : January 30, 2022


Arm Intervention/treatment
Experimental: 68Ga-DOTATATE PET/CT
Inject 68Ga-DOTATATE and then perform PET/CT scan
Drug: 68Ga-DOTATATE
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-DOTATATE. Tracer doses of 68Ga-DOTATATE will be used to image lesions of NET PET/CT scan.




Primary Outcome Measures :
  1. SUVmax [ Time Frame: through study completion, an average of 3 years ]
    SUVmax of focal lesions are measured on 68Ga-DOTATATE PET/CT. The SUVmax higher than that of the normal liver tissue is defined as positive.

  2. Diagnostic value [ Time Frame: through study completion, an average of 3 years ]
    Diagnostic value of 68Ga-DOTATE PET/CT for NET in comparison with 18F-FDG PET/CT


Secondary Outcome Measures :
  1. Diagnostic value in different grades/types of NET [ Time Frame: through study completion, an average of 3 years ]
    Diagnostic value of 68Ga-DOTATATE PET/CT in ectopic ACTH-secreting tumor, insulinoma, glucagonoma and so on.

  2. Overall Survival(OS) [ Time Frame: 1 year and 5 years after been diagnosed ]
    Analysis of OS for patients receiving 68Ga-DOTATATE PET/CT

  3. Progressive free survival(PFS) [ Time Frame: 1 year and 5 years after been diagnosed ]
    Analysis of PFS for patients receiving 68Ga-DOTATATE PET/CT

  4. SSTR expression/Ki67 and SUV [ Time Frame: through study completion, an average of 3 years ]
    Correlation between SSTR expression/Ki 67 and SUV in PET

  5. Risk stratification [ Time Frame: through study completion, an average of 3 years ]
    Analysis of risk factors and OS/PFS



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Ages Eligible for Study:   7 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • suspected or confirmed untreated NET patients previously performed 18F-FDG PET/CT signed written consent.

Exclusion Criteria:

  • pregnancy breastfeeding known allergy against TATE any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.

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): NCT04041882


Contacts
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Contact: Zhaohui Zhu, MD,PhD +86-10-69154196 zhuzhh@pumch.cn

Locations
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China
Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science Recruiting
Beijing, China
Contact: Zhaohui Zhu, MD,PhD    86-10-69154196    zhuzhh@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Chair: Zhaohui Zhu, MD,PhD Peking Union Medical College Hopital, Chinese Academy of Medical Science

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04041882     History of Changes
Other Study ID Numbers: PekingUMCH-NM022
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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