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

HTA Co., Ltd.

Status and phase: Active, not recruiting; Phase 3

Conditions: NETs

Treatments: Drug: 68Ga-DOTATATE Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07119242

YZGK-ZLYT-2023-Ⅲ-Ga

Details and patient eligibility

About

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

Enrollment: 95 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age > 18 years old, no gender limit;

2. Karnofsky status score >50 points;

3. Expected survival time >3 months;

4. 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);

5. The subjects or their guardians fully understand the content,process and possible risks of the trial and voluntarily sign the informed consent form.

Exclusion criteria

1. Known to be allergic to any components or excipients of 68Ga-DOTATATE injection;

2. 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;

3. Unable to complete the imaging examination specified in the plan due to claustrophobia,radiation phobia or personal wishes;

4. With a history of concurrent active infection or severe heart disease;

5. 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;

6. Those who receive long-term and repeated treatment with high-dose glucocorticoids;

7. 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;

8. 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

9. 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;

10. Investigators considered unsuitable to participate in this trial.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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95 participants in 1 patient group

68Ga-DOTATATE Injection

Experimental group

Treatment:

Drug: 68Ga-DOTATATE Injection