Evaluate the Diagnostic Efficacy, Pharmacokinetics and Safety of 68Ga-DOTATATE Injection PET/CT in NETs

NCT07119242 | Active Not Recruiting Phase 3

• 1 other identifier: YZGK-ZLYT-2023-Ⅲ-Ga
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the diagnostic efficacy, pharmacokinetics and safety of 68Ga-DOTATATE injection PET/CT in NETs

Conditions

NETs

Outcome Measures

Primary Outcomes (1)

• The sensitivity and specificity at the subject level

  The sensitivity and specificity at the subject level Sensitivity = Number of true positive/(Number of true positive + Number of false negative) Specificity = Number of true negative/(Number of true negative + Number of false positive)

  Within 28 days following 68Ga-DOTATATE injection PET/CT in NETs

Study Arms (1)

68Ga-DOTATATE Injection

EXPERIMENTAL

Drug: 68Ga-DOTATATE Injection

Interventions

68Ga-DOTATATE Injection DRUG

The eligible subjects who participate in 68Ga study will be intravenously injected with 68Ga-DOTATATE Injection on Day1，and undergo PET/CT examination within 60 minutes after injection. Corresponding safety examination is performed before administration of 68Ga-DOTATATE Injection, 3h±1.0h after administration, and Day2. Telephone safety visit is conducted at Day7 after administration.

68Ga-DOTATATE Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old, no gender limit;
• Karnofsky status score \>50 points;
• Expected survival time \>3 months;
• Those who have a history of neuroendocrine tumors,but require PET/CT examination for structure, location and function evaluation and disease management, and have measurable lesions; CT, MRI, 18F-FDG PET/CT or other imaging examinations are suspected of being NETs or those with space-occupying lesions and at least one of the following:
• ① Biochemical and tumor biomarkers results of blood or urine suggest that the subject is suspected of suffering from NETs (chromogranin A,neurospecific enolase,vasoactive intestinal peptide, serotonin (urinary 5-HIAA), gastrin, somatostatin,catecholamines,calcitonin,fasting insulin,C-Peptides(proinsulin) orglucagon abnormal biochemical indicators related to neuroen docrine tumors);
• ②Multiple endocrine neoplasia type 1 (MEN1) and Lindau syndrome (VHL) with familial tendency to be susceptible to NETs (symptomatic and/or asymptomatic cases; with biochemical or anatomical imaging evidence of the disease);
• The subjects or their guardians fully understand the content,process and possible risks of the trial and voluntarily sign the informed consent form.

You may not qualify if:

• Known to be allergic to any components or excipients of 68Ga-DOTATATE injection;
• Unable to remain relatively still during the imaging examination (such as coughing, severe arthritis, etc.), or body shape and/or weight exceeds the applicable range of the examination equipment;
• Unable to complete the imaging examination specified in the plan due to claustrophobia,radiation phobia or personal wishes;
• With a history of concurrent active infection or severe heart disease;
• Those who have used long-acting somatostatin analogs within 28 days or short-acting somatostatin analogs within 2 days before the scheduled PET/CT examination of 68Ga-DOTATATE injection;
• Those who receive long-term and repeated treatment with high-dose glucocorticoids;
• Pregnant or lactating women,or those who do not agree to take effective contraceptive measures from the date of signing the informed consent form to 3 months after administration;
• Blood test results
• a) WBC: \< 2 x 109/L, b) Haemoglobin:\< 8.0 g/dL, c) Platelets: s 50 x 109/L, d) ALT. AST. AP:\> 5 times ULN, e) Bilirubin:\> 3 times ULN, f) Serum creatinine:\> 1.5 times ULN
• Those who have participated in other interventional clinical trials or are participating in other interventional clinical trials within 1 month or 5 drug half-lives( whichever is longer ) before the date of signing the informed consent,or have participated in clinical trials of radioactive drugs within 1 year before the date of signing the informed consent, and the withdrawal time is less than 3 months until the date of signing the informed consent;
• Investigators considered unsuitable to participate in this trial.

Sponsors & Collaborators

• HTA Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Interventions

gallium Ga 68 dotatate

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: September 13, 2024
• First Posted: August 13, 2025
• Study Start: January 8, 2024
• Primary Completion: November 11, 2024
• Study Completion: December 31, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CN (1)