68Ga-DOTATATE PET/CT in Neuroendocrine Tumor

NCT04041882 | Unknown Early Phase 1

• 1 other identifier: PekingUMCH-NM022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Diagnostic value in different grades/types of NET

  through study completion, an average of 3 years

• Overall Survival(OS)

  1 year and 5 years after been diagnosed

• Progressive free survival(PFS)

  1 year and 5 years after been diagnosed

• SSTR expression/Ki67 and SUV

  through study completion, an average of 3 years

• Risk stratification

  through study completion, an average of 3 years

Study Arms (1)

68Ga-DOTATATE PET/CT

EXPERIMENTAL

Inject 68Ga-DOTATATE and then perform PET/CT scan

Drug: 68Ga-DOTATATE

Interventions

68Ga-DOTATATE DRUG

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.

68Ga-DOTATATE PET/CT

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science

Beijing, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 34146130 DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

gallium Ga 68 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Zhaohui Zhu, MD,PhD

  Peking Union Medical College Hopital, Chinese Academy of Medical Science

  STUDY CHAIR

Central Study Contacts

Zhaohui Zhu, MD,PhD

CONTACT

+86-10-69154196; zhuzhh@pumch.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: April 1, 2014
• Primary Completion: December 30, 2020
• Study Completion: January 30, 2022
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)