Clinical trial NCT04041882: 68Ga-DOTATATE PET/CT in Neuroendocrine Tumor
Official title: 68Ga-DOTATATE PET/CT for Detection and Evaluation of Neuroendocrine Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Neuroendocrine Tumors
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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.

Primary outcomes:
measure: SUVmax
timeFrame: through study completion, an average of 3 years
measure: Diagnostic value
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: Diagnostic value in different grades/types of NET
timeFrame: through study completion, an average of 3 years
measure: Overall Survival(OS)
timeFrame: 1 year and 5 years after been diagnosed
measure: Progressive free survival(PFS)
timeFrame: 1 year and 5 years after been diagnosed
measure: SSTR expression/Ki67 and SUV
timeFrame: through study completion, an average of 3 years
measure: Risk stratification
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science
Study officials:
affiliation: Peking Union Medical College Hopital, Chinese Academy of Medical Science
name: Zhaohui Zhu, MD,PhD
role: STUDY_CHAIR
References:
citation: Liu Q, Zang J, Yang Y, Ling Q, Wu H, Wang P, Lu L, Zhu Z. Head-to-head comparison of 68Ga-DOTATATE PET/CT and 18F-FDG PET/CT in localizing tumors with ectopic adrenocorticotropic hormone secretion: a prospective study. Eur J Nucl Med Mol Imaging. 2021 Dec;48(13):4386-4395. doi: 10.1007/s00259-021-05370-8. Epub 2021 Jun 19.