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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

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;

Show all 11Show fewer

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

Other trials in China

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 groups in NCT07119242
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.

8 Jan 202431 Dec 2025

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
Gastroenteropancreatic Neuroendocrine Tumors
RecruitingPhase 1
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
Somatostatin Receptor Positive, NETs
Not yet recruitingObservational study
Real World Positioning of Tyrosine Kinase Inhibitors (TKIs) Within Systemic Treatment Strategies for Advanced Neuroendocrine Tumors (NETs)
Well-Differentiated Neuroendocrine Tumors (NETs)

All NETs trials

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.

Related trials for NETs

RecruitingPhase 1
Study of RYZ401 in Subjects With Solid Tumors Expressing SSTRs.
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
Not yet recruitingPhase 3
TRINITY TRIAL; Trial Of PRRT Plus CAPTEM Vs CAPTEM Alone In Well Differentiated GEP NETS
Gastroenteropancreatic Neuroendocrine Tumors
RecruitingPhase 1
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
Somatostatin Receptor Positive, NETs
Not yet recruitingObservational study
Real World Positioning of Tyrosine Kinase Inhibitors (TKIs) Within Systemic Treatment Strategies for Advanced Neuroendocrine Tumors (NETs)
Well-Differentiated Neuroendocrine Tumors (NETs)

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?

On the ClinicalTrials.gov record for NCT07119242.

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.