Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor

NCT ID: NCT05749289

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2025-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Neuroendocrine Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Al18F-octreotide

Intervention Type DRUG

Al18F-octreotide I was injected into the patients before the PET/CT scans

Interventions

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Al18F-octreotide

Al18F-octreotide I was injected into the patients before the PET/CT scans

Intervention Type DRUG

Other Intervention Names

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Al18F-NOTA-TATE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rong Zheng, M.D.

Role: STUDY_DIRECTOR

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC

Locations

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National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Chao Yang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gouzhu Hou, M.D.

Role: CONTACT

15611145656

Xin Cheng, M.D.

Role: CONTACT

15120002998

Facility Contacts

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Guozhu Hou, M.D.

Role: primary

15611145656

Other Identifiers

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NCC 3744

Identifier Type: -

Identifier Source: org_study_id

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