68Ga-DOTATATE PET/CT in Neuroendocrine Tumor

Sponsor

Peking Union Medical College Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04041882

Collaborator

(none)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

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:

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

Actual Study Start Date :

Apr 1, 2014

Anticipated Primary Completion Date :

Dec 30, 2020

Anticipated Study Completion Date :

Jan 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

SUVmax [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.
Diagnostic value [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

Diagnostic value in different grades/types of NET [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.
Overall Survival(OS) [1 year and 5 years after been diagnosed]
Analysis of OS for patients receiving 68Ga-DOTATATE PET/CT
Progressive free survival(PFS) [1 year and 5 years after been diagnosed]
Analysis of PFS for patients receiving 68Ga-DOTATATE PET/CT
SSTR expression/Ki67 and SUV [through study completion, an average of 3 years]
Correlation between SSTR expression/Ki 67 and SUV in PET
Risk stratification [through study completion, an average of 3 years]
Analysis of risk factors and OS/PFS

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science	Beijing		China

Sponsors and Collaborators

Peking Union Medical College Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peking Union Medical College Hospital

ClinicalTrials.gov Identifier:

NCT04041882

Other Study ID Numbers:

PekingUMCH-NM022

First Posted:

Aug 1, 2019

Last Update Posted:

Aug 1, 2019

Last Verified:

Jul 1, 2019

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 Aug 1, 2019