Application of Al18F-octreotide PET/CT in Tumors With Positive SSTR Expression

March 31, 2026 updated by: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
This is an open-label whole-body PET/CT study for investigating the value of Al18F-octreotide PET/CT in patients with SSTR positive tumors

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Hepatocellular carcinoma, and meningioma. 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 SSTR positive tumors 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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with suspected or clearly diagnosed SSTR positive tumors
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Al18F-octreotide PET/CT
Al18F-octreotide PET/CT will be performed on patients with suspected or clearly diagnosed SSTR positive tumors . 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic value
Time Frame: through study completion, an average of 1 year]
Sensitivity and Specificity of Al18F-octreotide PET/CT for SSTR positive tumors
through study completion, an average of 1 year]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2022

Primary Completion (Estimated)

December 20, 2028

Study Completion (Estimated)

December 20, 2029

Study Registration Dates

First Submitted

February 19, 2023

First Submitted That Met QC Criteria

February 19, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC 3744

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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