Neuroendocrine NeoplasmsPhase 1/2NCT07835906
68Ga-NYM215 in NENs
A Phase 1/2 study testing 68Ga-NYM215 PET/CT and 68Ga-DOTATATE PET/CT in people with Neuroendocrine Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This prospective study will evaluate the safety, biodistribution, dosimetry, and imaging performance of 68Ga-NYM215 PET/CT in patients with neuroendocrine neoplasms. An head-to-head comparison with 68Ga-DOTATATE PET/CT will assess the diagnostic performance of 68Ga-NYM215 PET/CT at both the patient and lesion levels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Neoplasms
- What is being tested?
- 68Ga-NYM215 PET/CT and 68Ga-DOTATATE PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2026to 20 Oct 2027
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years.
- Histopathologically confirmed neuroendocrine tumor.
- At least one suspected lesion based on other imaging findings or clinical assessment.
Who cannot join
- Combined with other types of tumors.
- Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR#30ml/min).
- Active infection.
- Pregnant or breastfeeding women.
- Inability to undergo PET/CT imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Safety, Biodistribution, Dosimetry of 68Ga-NYM215 PET/CT and Head-to-head Comparison With 68Ga-DOTATATE PET/CT in Patients With Neuroendocrine Neoplasms: A Prospective Study
This prospective study will evaluate the safety, biodistribution, dosimetry, and imaging performance of 68Ga-NYM215 PET/CT in patients with neuroendocrine neoplasms. An head-to-head comparison with 68Ga-DOTATATE PET/CT will assess the diagnostic performance of 68Ga-NYM215 PET/CT at both the patient and lesion levels.
Read the detailed description
Neuroendocrine neoplasms (NENs) are a heterogeneous group of neoplasms that frequently overexpress somatostatin receptors (SSTRs), particularly SSTR subtype 2 (SSTR2), which provide specific targets for both imaging and therapy. As a somatostatin receptor agonist, 68Ga-DOTATATE PET/CT is an established imaging modality for the detection, staging, restaging, and treatment selection of patients with NETs.
SSTR antagonists may show lower physiologic uptake in abdominal organs and have demonstrated potential for improved lesion detection compared with SSTR agonists. 68Ga-NYM215 is a novel SSTR antagonist with high receptor affinity. In preclinical SSTR-positive animal models, 68Ga-NYM215 demonstrated favorable safety, biodistribution, and tumor uptake.The purpose of this study is to investigate the biodistribution, safety, and diagnostic ability of 68Ga-NYM215 in patients with NETs. And compare the diagnostic ability of 68Ga-NYM215 with 68Ga-DOTATATE PET/CT.
This prospective study will enroll patients with pathologically confirmed NENs. All participants will undergo both 68Ga-NYM215 PET/CT and 68Ga-DOTATATE PET/CT. For radiation dosimetry, the first 8 participants will undergo serial 68Ga-NYM215 PET imaging at 5, 15, 30, 45, 60, and 120 minutes after 68Ga-NYM215 administration. Subsequent participants will undergo whole-body 68Ga-NYM215 PET/CT at 40 to 60 minutes after administration. All participants will undergo whole-body 68Ga-DOTATATE PET/CT at 40 to 60 minutes after radiotracer administration. The two PET/CT examinations will be performed within 1 week, with an interval of at least 24 hours to minimize potential cross-interference.
Results were determined by two nuclear medicine physicians through consensus, with disagreements adjudicated through concurrent image interpretation involving a third senior physician. For each examination, lesions will be documented according to number, anatomical location, size, SUVmax, and tumor-to-background ratio (TBR).
The study will explore the safety, biodistribution, radiation dosimetry, and diagnostic performance of 68Ga-NYM215 PET/CT. A head-to-head comparison with 68Ga-DOTATATE PET/CT will be performed to compare the diagnostic performance at both the patient and lesion levels.
- Conditions
- Neuroendocrine Neoplasms
- Being tested
- 68Ga-NYM215 PET/CT, 68Ga-DOTATATE PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NYM215 PET/CTDiagnostic test
40 patients will be enrolled in this arm. Each patients will be injected with approximately 3mCi 68Ga-NYM215. The first 8 participants will undergo serial 68Ga-NYM215 PET imaging at 5, 15, 30, 45, 60, and 120 minutes after 68Ga-NYM215 administration. Subsequent participants will undergo whole-body 68Ga-NYM215 PET/CT at 40 to 60 minutes after administration.
68Ga-DOTATATE PET/CTDiagnostic test
Each patients will be injected with approximately 3mCi 68Ga-DOTATATE. All participants will undergo whole-body 68Ga-DOTATATE PET/CT at 40 to 60 minutes after radiotracer administration. The two PET/CT examinations will be performed within 1 week, with an interval of at least 24 hours to minimize potential cross-interference.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-NYM215 and Comparator 68Ga-DOTATATE PET/CT | Experimental | Patients will perform a 68Ga-NYM215 PET/CT as well as a 68Ga-DOTATATE PET/CT. Receives: Diagnostic Test: 68Ga-NYM215 PET/CT; Diagnostic Test: 68Ga-DOTATATE PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
Diagnostic efficacy of 68Ga-NYM215 PET/CT compared with 68Ga-DOTATATE PET/CT in the same participant, assessed on both a per-patient and per-lesion basis. Per-patient analysis will compare lesion detection rate. Per-lesion analysis will compare lesion detection rate, lesion number, size, SUVmax, and tumor-to-background ratio (TBR).
Measured: At the time of paired PET/CT imaging, within 1 week.
Safety
Adverse effects after radiotracer injection.
Measured: From radiotracer injection to 24 hours post-injection.
Secondary outcomes (2)
Biodistribution
The biodistribution of 68Ga-NYM215 will be evaluated in the following organs: pituitary gland, parotids, thyroids, lungs, blood pool, liver, spleen, pancreas (head and uncinate process), gallbladder, stomach, small intestine, kidneys, and adrenal glands.
Measured: Through study completion, within 1 week.
Dosimetry
Absorbed dose for target organs, urinary bladder residence time, and whole-body effective dose were determined for 68Ga-NYM215.
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion20 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine NeoplasmsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07835906
- Sponsor's protocol ID
- PUMCH-NYNEN
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Biodistribution, Dosimetry of 68Ga-NYM215 PET/CT and Head-to-head Comparison With 68Ga-DOTATATE PET/CT in Patients With Neuroendocrine Neoplasms: A Prospective Study
- ClinicalTrials.gov ID
- NCT07835906
- Acronym / sponsor ID
- PUMCH-NYNEN
- Conditions
- Neuroendocrine Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 20 Oct 2027 (estimated)
- First posted
- 23 Sep 2026 (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.
This prospective study will evaluate the safety, biodistribution, dosimetry, and imaging performance of 68Ga-NYM215 PET/CT in patients with neuroendocrine neoplasms. An head-to-head comparison with 68Ga-DOTATATE PET/CT will assess the diagnostic performance of 68Ga-NYM215 PET/CT at both the patient and lesion levels.
Detailed description
Neuroendocrine neoplasms (NENs) are a heterogeneous group of neoplasms that frequently overexpress somatostatin receptors (SSTRs), particularly SSTR subtype 2 (SSTR2), which provide specific targets for both imaging and therapy. As a somatostatin receptor agonist, 68Ga-DOTATATE PET/CT is an established imaging modality for the detection, staging, restaging, and treatment selection of patients with NETs.
SSTR antagonists may show lower physiologic uptake in abdominal organs and have demonstrated potential for improved lesion detection compared with SSTR agonists. 68Ga-NYM215 is a novel SSTR antagonist with high receptor affinity. In preclinical SSTR-positive animal models, 68Ga-NYM215 demonstrated favorable safety, biodistribution, and tumor uptake.The purpose of this study is to investigate the biodistribution, safety, and diagnostic ability of 68Ga-NYM215 in patients with NETs. And compare the diagnostic ability of 68Ga-NYM215 with 68Ga-DOTATATE PET/CT.
This prospective study will enroll patients with pathologically confirmed NENs. All participants will undergo both 68Ga-NYM215 PET/CT and 68Ga-DOTATATE PET/CT. For radiation dosimetry, the first 8 participants will undergo serial 68Ga-NYM215 PET imaging at 5, 15, 30, 45, 60, and 120 minutes after 68Ga-NYM215 administration. Subsequent participants will undergo whole-body 68Ga-NYM215 PET/CT at 40 to 60 minutes after administration. All participants will undergo whole-body 68Ga-DOTATATE PET/CT at 40 to 60 minutes after radiotracer administration. The two PET/CT examinations will be performed within 1 week, with an interval of at least 24 hours to minimize potential cross-interference.
Results were determined by two nuclear medicine physicians through consensus, with disagreements adjudicated through concurrent image interpretation involving a third senior physician. For each examination, lesions will be documented according to number, anatomical location, size, SUVmax, and tumor-to-background ratio (TBR).
The study will explore the safety, biodistribution, radiation dosimetry, and diagnostic performance of 68Ga-NYM215 PET/CT. A head-to-head comparison with 68Ga-DOTATATE PET/CT will be performed to compare the diagnostic performance at both the patient and lesion levels.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-NYM215 and Comparator 68Ga-DOTATATE PET/CT | Experimental | Diagnostic Test: 68Ga-NYM215 PET/CT, Diagnostic Test: 68Ga-DOTATATE PET/CTPatients will perform a 68Ga-NYM215 PET/CT as well as a 68Ga-DOTATATE PET/CT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 80 years.
- Histopathologically confirmed neuroendocrine tumor.
- At least one suspected lesion based on other imaging findings or clinical assessment.
Key exclusion criteria (5 listed)
- Combined with other types of tumors.
- Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR#30ml/min).
- Active infection.
- Pregnant or breastfeeding women.
- Inability to undergo PET/CT imaging.
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-NYM215 PET/CT40 patients will be enrolled in this arm. Each patients will be injected with approximately 3mCi 68Ga-NYM215. The first 8 participants will undergo serial 68Ga-NYM215 PET imaging at 5, 15, 30, 45, 60, and 120 minutes after 68Ga-NYM215 administration. Subsequent participants will undergo whole-body 68Ga-NYM215 PET/CT at 40 to 60 minutes after administration. | Diagnostic test | 68Ga-NYM215 and Comparator 68Ga-DOTATATE PET/CT |
| 68Ga-DOTATATE PET/CTEach patients will be injected with approximately 3mCi 68Ga-DOTATATE. All participants will undergo whole-body 68Ga-DOTATATE PET/CT at 40 to 60 minutes after radiotracer administration. The two PET/CT examinations will be performed within 1 week, with an interval of at least 24 hours to minimize potential cross-interference. | Diagnostic test | 68Ga-NYM215 and Comparator 68Ga-DOTATATE PET/CT |
Primary outcome
Diagnostic efficacy
Time frame: At the time of paired PET/CT imaging, within 1 week.
Diagnostic efficacy of 68Ga-NYM215 PET/CT compared with 68Ga-DOTATATE PET/CT in the same participant, assessed on both a per-patient and per-lesion basis. Per-patient analysis will compare lesion detection rate. Per-lesion analysis will compare lesion detection rate, lesion number, size, SUVmax, and tumor-to-background ratio (TBR).
Safety
Time frame: From radiotracer injection to 24 hours post-injection.
Adverse effects after radiotracer injection.
2 secondary outcomes
Biodistribution
Time frame: Through study completion, within 1 week.
Dosimetry
Time frame: Through study completion, an average of 6 months.
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 23 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-NYM215 PET/CT and 68Ga-DOTATATE PET/CT in people with Neuroendocrine Neoplasms, run by Peking Union Medical College Hospital 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Sep 2026. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Meixi Liu, MD (+86-15010405355, meixiliu_pumc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy (time frame: At the time of paired PET/CT imaging, within 1 week.). The study lists 2 primary outcomes in all. 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 23 Sep 2026.