NCT06091748

Brief Summary

This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

February 22, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

October 16, 2023

Last Update Submit

May 28, 2025

Conditions

Advanced Gastroenteropancreatic Neuroendocrine Tumor

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET

    The number of patients with SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth

    12 months

  • Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET

    The number of patients who have no SSTR (+) GEP-NETs disease that was confirmed by imaging using 68Ga-DOTATOC PET/CT and Standard of Truth

    12 months

Secondary Outcomes (1)

  • Incidence and severity of AE and SAE

    up to 1 year follow-up

Study Arms (1)

PET/CT imaging with 68Ga-DOTATOC

EXPERIMENTAL
Drug: 68Ga-DOTATOC

Interventions

68Ga-DOTATOCDRUG

Detection of somatostatin positive lesions in GEP-NETs

PET/CT imaging with 68Ga-DOTATOC

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able and willing to provide a written informed consent;
  • \~75 years old,male or female；
  • ECOG performance status 0 or 1;
  • Confirmed or suspicion of GEP-NET.

You may not qualify if:

  • Unable to lie flat for the entire imaging duration (e.g. persistent cough, claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device;
  • Individuals planning to be pregnant, and lactating women;
  • Individuals with concurrent active infections or with unexplained fever \>38.5°C for more than 1 hour during the screening period or prior to administration of investigational medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Ga(III)-DOTATOC

Central Study Contacts

Pan Huang

CONTACT

+0518-82342973pan.huang.ph18@hengrui.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 19, 2023

Study Start

February 22, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

June 3, 2025

Record last verified: 2025-05

Locations

CN(1)