SSTR Positive TumorsPhase 2/3NCT05749289
Application of Al18F-octreotide PET/CT in Tumors With Positive SSTR Expression
A Phase 2/3 study testing Al18F-octreotide in people with SSTR Positive Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SSTR Positive Tumors
- What is being tested?
- Al18F-octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2022to 20 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected or clearly diagnosed SSTR positive tumors
- signed written consent.
- Willing and able to cooperate with all projects in this study.
Who cannot join
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Chao Yang, 100021
Guozhu Hou, M.D., 15611145656, 15611145656@163.com
About this study
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.
- Conditions
- SSTR Positive Tumors
- Being tested
- Al18F-octreotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al18F-octreotideDrug
Also called Al18F-NOTA-TATE
Al18F-octreotide I was injected into the patients before the PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| Al18F-octreotide PET/CT | Experimental | 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. Receives: Drug: Al18F-octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and Specificity of Al18F-octreotide PET/CT for SSTR positive tumors
Measured: through study completion, an average of 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start20 Dec 2022
- Primary completion20 Dec 2028 (estimated)
- Study completion20 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SSTR Positive TumorsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong Zheng, M.D., Study director, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749289
- Sponsor's protocol ID
- NCC 3744
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Al18F-octreotide PET/CT in Tumors With Positive SSTR Expression
- ClinicalTrials.gov ID
- NCT05749289
- Acronym / sponsor ID
- NCC 3744
- Conditions
- SSTR Positive Tumors
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 20 Dec 2029 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Al18F-octreotide PET/CT | Experimental | Drug: Al18F-octreotideAl18F-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with suspected or clearly diagnosed SSTR positive tumors
- signed written consent.
- Willing and able to cooperate with all projects in this study.
Key exclusion criteria (3 listed)
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Al18F-octreotideAlso: Al18F-NOTA-TATEAl18F-octreotide I was injected into the patients before the PET/CT scans | Drug | Al18F-octreotide PET/CT |
Primary outcome
Diagnostic value
Time frame: through study completion, an average of 1 year]
Sensitivity and Specificity of Al18F-octreotide PET/CT for SSTR positive tumors
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rong Zheng, M.D. study director
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Al18F-octreotide in people with SSTR Positive Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gouzhu Hou, M.D. (15611145656, 15611145656@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value (time frame: through study completion, an average of 1 year]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.