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Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT05749289
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label whole-body PET/CT study for investigating the value of Al18F-octreotide PET/CT in patients with Neuroendocrine Tumor

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Octreotide is an artificial replacement for the natural growth hormone inhibitor in humans. It is a small peptide hormone consisting of 14 amino acids and is widely distributed in neuroendocrine cells, with the highest density in the brain, peripheral neurons, endocrine pancreas and gastrointestinal tract. Under pathological conditions, some tumour cells show overexpression of growth inhibitory receptors, such as endocrine tumours of the pancreas, pituitary adenomas, pheochromocytomas, paragangliomas, carcinoid tumours, medullary thyroid carcinomas, small cell lung carcinomas and other neuroendocrine tumours. Therefore, the sensitivity and specificity of octreotide imaging is high.

This study will provide a visual, reproducible and non-invasive imaging method for the diagnosis of neuroendocrine tumours through Al18F-octreotide PCT/CT imaging, providing an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment, contributing to the development of medicine and science in the field of positron imaging.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor
Actual Study Start Date :
Dec 20, 2022
Anticipated Primary Completion Date :
Dec 20, 2023
Anticipated Study Completion Date :
Dec 20, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Al18F-octreotide PET/CT

Al18F-octreotide PET/CT will be performed on patients with suspected or clearly diagnosed Neuroendocrine Tumor. The patients were injected with Al18F-octreotide and underwent PET/CT scan 20~40min after the injection.

Drug: Al18F-octreotide
Al18F-octreotide I was injected into the patients before the PET/CT scans
Other Names:
  • Al18F-NOTA-TATE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic value [through study completion, an average of 1 year]]

      Sensitivity and Specificity of Al18F-octreotide PET/CT for Neuroendocrine Tumor

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with suspected or clearly diagnosed Neuroendocrine Tumor

    • signed written consent.

    • Willing and able to cooperate with all projects in this study.

    Exclusion Criteria:

    • pregnancy;

    • breastfeeding;

    • 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 National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College Beijing Chao Yang China 100021

    Sponsors and Collaborators

    • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Investigators

    • Study Director: Rong Zheng, M.D., National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT05749289
    Other Study ID Numbers:
    • NCC 3744
    First Posted:
    Mar 1, 2023
    Last Update Posted:
    Mar 1, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neuroendocrine Tumors
    Octreotide

    Study Results

    No Results Posted as of Mar 1, 2023