68Ga-DOTATATE PET/CT in Neuroendocrine Tumor

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04041882
• Other study ID #: PekingUMCH-NM022
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2014
• Est. completion date: January 30, 2022

Study information

• Verified date: July 2019
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD,PhD
• Phone: +86-10-69154196
• Email: zhuzhh[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 30, 2022
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

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.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

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