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RecruitingNCT06690957Updated Sep 8, 2026

Somatostatin Receptor PET/CT in SSTR-Related Disease Patients

An observational study in SSTR-related Disease, Tumor and Positron Emission Tomography, sponsored by Tianjin Medical University. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Primary conditionNeoplasm MetastasisRegistry: NeoplasmsReclassifiedWhy we changed it
Registry
Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Neoplasm Metastasis
Why
  1. The study's listed conditions name Neoplasm Metastasis, a narrower term within Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Tianjin Medical University · Observational

From the registry’s dates

  • Started Feb 2019; still recruiting 7 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 80 Years
Sex
All
01

Study summary

To evaluate the potential usefulness of 68Ga/18F-TATE/JR11/LM3 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various SSTR-related disease patients.

Read the detailed description

Subjects with various SSTR-related disease patients underwent 68Ga/18F-TATE/JR11/ LM3 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-TATE/JR11/LM3 PET/CT were calculated.

02

Conditions studied

  • SSTR-related Disease
  • Tumor
  • Positron Emission Tomography
  • Metastasis

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Keywords

  • PET/CT
  • SSTR
  • Angonist
  • Antagonist
03

In context

Neoplasm Metastasis Reclassified

4,040 studies on the registry are indexed under Neoplasm Metastasis; 886 are open to participants now.

This study's planned enrollment of 500 is above the median of 136 across 557 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Tianjin Medical University is the lead sponsor of 49 studies on the registry; 30 are open to participants now.

Compared within Neoplasm Metastasis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled SSTR PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled SSTR PET/CT scan; (iv) patients who were able to provide (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written .

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
7 Days
Patient registry
Yes

Groups and cohorts

  • Diagnostic Test: Single Group Assignment

    Each subject receive a single intravenous injection of 68Ga/18F-TATE/JR11/LM3 , and undergo PET/CT imaging within the specificed time.

    Diagnostic Test: 68Ga/18F-TATE/JR11/LM3

Interventions

  • Diagnostic test68Ga/18F-TATE/JR11/LM3

    Each subject receive a single intravenous injection of 68Ga/18F-TATE/JR11/LM3, and undergo PET/CT imaging within the specificed time.

06

What researchers measure

Primary outcomes

  1. Standardized uptake value (SUV)

    Standardized uptake value (SUV) of tracers for each target lesion of subject or suspected primary tumor or/and metastasis.

    Time frame: 30 days

Secondary outcomes

  1. Diagnostic efficacy

    The sensitivity, specificity and accuracy of SSTR-PET/CT were calculated.

    Time frame: 30 days

07

Study locations

3 of 3 sites recruiting
08

References and documents

Publications

  • Yu H, Bao X, Gu Y, Pan M, He Q, Li D, Chen Q, Yao S. Comparison of PET/CT using 68Ga-NOTA-Exendin-4 with 68Ga-DOTATATE, 18F-FDG, and conventional imaging in the localization of insulinomas. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4102-4111. doi: 10.1007/s00259-025-07288-x. Epub 2025 Apr 22. PubMed 40259061 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2019 (actual). Primary completion is estimated for Oct 2027, 104 months after the start.

Of 209 non-industry observational studies under Neoplasm Metastasis, half reached primary completion within 75 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 172. This study's planned 104 months is above that.

Counting every sponsor, half of 240 studies reached it within 66 months; a quarter within 35 and three quarters within 172.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2024
First posted
Nov 15, 2024
StartActual
Feb 1, 2019
Primary completionEst.
Oct 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06690957
Lead sponsor
Tianjin Medical University
Collaborators
Tianjin Medical University General Hospital
Responsible party
Shaobo Yao, PhD (Prof., Tianjin Medical University) — Principal investigator
First posted
Nov 15, 2024
Start date
Feb 1, 2019
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Sep 8, 2026

Study contacts

Haonan Yu, MD
Contact
dreamadam@126.com
+8613821000597
Shaobo Yao, PhD
Contact
yaoshaobo008@163.com
+8615122570279

Oversight

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

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