Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06091748
• Collaborator: (none)
• Enrollment: 66
• Arm: 1
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Gastroenteropancreatic Neuroendocrine Tumor	Drug: 68Ga-DOTATOC	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2024
• Anticipated Study Completion Date: Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PET/CT imaging with 68Ga-DOTATOC	Drug: 68Ga-DOTATOC; Detection of somatostatin positive lesions in GEP-NETs

Outcome Measures

Primary Outcome Measures

1. Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET [12 months]

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

2. Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET [12 months]

   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

Secondary Outcome Measures

1. Incidence and severity of AE and SAE [up to 1 year follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Able and willing to provide a written informed consent;

2. 18~75 years old,male or female；

3. ECOG performance status 0 or 1;

4. Confirmed or suspicion of GEP-NET.

Exclusion Criteria:

1. Unable to lie flat for the entire imaging duration (e.g. persistent cough, claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device;

2. Individuals planning to be pregnant, and lactating women;

3. 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06091748
• Other Study ID Numbers: HRFS-Q-2010-301
• First Posted: Oct 19, 2023
• Last Update Posted: Oct 19, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuroendocrine Tumors; Edotreotide

Study Results

No Results Posted as of Oct 19, 2023