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68Ga-NYM215 in NENs

ConditionNeuroendocrine Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 80 years.

Histopathologically confirmed neuroendocrine tumor.

At least one suspected lesion based on other imaging findings or clinical assessment.

Disqualifiers

Combined with other types of tumors.

Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR#30ml/min).

Active infection.

Pregnant or breastfeeding women.

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-NYM215 PET/CT

    Diagnostic 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/CT

    Diagnostic 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: 68Ga-NYM215 and Comparator 68Ga-DOTATATE PET/CTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
At the time of paired PET/CT imaging, within 1 week.
2

Safety

Adverse effects after radiotracer injection.

Time frame
From radiotracer injection to 24 hours post-injection.

Secondary outcomes

1

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.

Time frame
Through study completion, within 1 week.
2

Dosimetry

Absorbed dose for target organs, urinary bladder residence time, and whole-body effective dose were determined for 68Ga-NYM215.

Time frame
Through study completion, an average of 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: