68Ga-DOTATATE PET/CT in Neuroendocrine Tumor

July 30, 2019 updated by: Peking Union Medical College Hospital

68Ga-DOTATATE PET/CT for Detection and Evaluation of Neuroendocrine Tumor

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 3 years
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
through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 3 years
Overall Survival(OS)
Time Frame: 1 year and 5 years after been diagnosed
Analysis of OS for patients receiving 68Ga-DOTATATE PET/CT
1 year and 5 years after been diagnosed
Progressive free survival(PFS)
Time Frame: 1 year and 5 years after been diagnosed
Analysis of PFS for patients receiving 68Ga-DOTATATE PET/CT
1 year and 5 years after been diagnosed
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
through study completion, an average of 3 years
Risk stratification
Time Frame: through study completion, an average of 3 years
Analysis of risk factors and OS/PFS
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Zhaohui Zhu, MD,PhD, Peking Union Medical College Hopital, Chinese Academy of Medical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Anticipated)

December 30, 2020

Study Completion (Anticipated)

January 30, 2022

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 30, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUMCH-NM022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuroendocrine Tumors

Clinical Trials on 68Ga-DOTATATE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe