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RecruitingNCT05749289Updated Apr 6, 2026

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

A Phase 2/3 interventional study of Al18F-octreotide in SSTR Positive Tumors, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.

Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2/3, Interventional, and Diagnostic

From the registry’s dates

  • Started Dec 2022; still recruiting 3 years 9 months later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • SSTR Positive Tumors
03

In context

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • pregnancy;
  • breastfeeding;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • 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

Interventions

  • DrugAl18F-octreotide

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

    Also known as: Al18F-NOTA-TATE

06

What researchers measure

Primary outcomes

  1. Diagnostic value

    Sensitivity and Specificity of Al18F-octreotide PET/CT for SSTR positive tumors

    Time frame: through study completion, an average of 1 year]

07

Study locations

1 of 1 sites recruiting
  • National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, Chao Yang 100021, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05749289
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Responsible party
Sponsor
First posted
Mar 1, 2023
Start date
Dec 20, 2022
Primary completion
Dec 20, 2028 (estimated)
Completion
Dec 20, 2029 (estimated)
Last update
Apr 6, 2026

Study contacts

Gouzhu Hou, M.D.
Contact
15611145656@163.com
15611145656
Xin Cheng, M.D.
Contact
cxpumc@foxmail.com
15120002998
Rong Zheng, M.D.
study director · National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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