NETsPhase 3NCT07119242
Evaluate the Diagnostic Efficacy, Pharmacokinetics and Safety of 68Ga-DOTATATE Injection PET/CT in NETs
A Phase 3 study testing 68Ga-DOTATATE Injection in people with NETs, run by HTA Co., Ltd. at 1 site in China.
Trial summary
Evaluate the diagnostic efficacy, pharmacokinetics and safety of 68Ga-DOTATATE injection PET/CT in NETs Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NETs
- What is being tested?
- 68Ga-DOTATATE Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2024to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Evaluate the diagnostic efficacy, pharmacokinetics and safety of 68Ga-DOTATATE injection PET/CT in NETs
- Conditions
- NETs
- Being tested
- 68Ga-DOTATATE Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATATE InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-DOTATATE Injection | Experimental | Not described Receives: Drug: 68Ga-DOTATATE Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 28 days following 68Ga-DOTATATE injection PET/CT in NETs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start8 Jan 2024
- Primary completion11 Nov 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NETsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HTA Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119242
- Sponsor's protocol ID
- YZGK-ZLYT-2023-Ⅲ-Ga
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Diagnostic Efficacy, Pharmacokinetics and Safety of 68Ga-DOTATATE Injection PET/CT in NETs
- ClinicalTrials.gov ID
- NCT07119242
- Acronym / sponsor ID
- YZGK-ZLYT-2023-Ⅲ-Ga
- Conditions
- NETs
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- HTA Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the diagnostic efficacy, pharmacokinetics and safety of 68Ga-DOTATATE injection PET/CT in NETs
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-DOTATATE Injection | Experimental | Drug: 68Ga-DOTATATE Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-DOTATATE InjectionThe 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. | Drug | 68Ga-DOTATATE Injection |
Primary outcome
The sensitivity and specificity at the subject level
Time frame: Within 28 days following 68Ga-DOTATATE injection PET/CT in NETs
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 68Ga-DOTATATE Injection in people with NETs, run by HTA Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity at the subject level (time frame: Within 28 days following 68Ga-DOTATATE injection PET/CT in NETs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.