68Ga-NYM096 PET/CT imaging in different cancers
68Ga-NYM096 PET/CT: Tracer Uptake in Various Kinds of Cancer
This study will see if a single injection of 68Ga-NYM096 followed by whole-body PET/CT can highlight primary and metastatic cancer lesions in adults with confirmed tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | girentuximab, sunitinib, cabozantinib, lenvatinib |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07144748 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center imaging study in which each participant receives a single intravenous dose of 68Ga-NYM096 followed by dedicated whole-body PET/CT. Scans are performed when referring physicians consider standard 18F-FDG PET/CT or other imaging insufficient. Quantitative image analyses will measure lesion number, SUVmax (40% isocontour), and tumor-to-background ratios across primary and metastatic sites. Up to 120 patients with histologically proven tumors or unequivocal metastases will be enrolled to define tumor uptake patterns and identify promising indications for future use.
Who should consider this trial
Good fit: Adults (≥18 years) with histopathologically confirmed primary tumors or unequivocal metastatic lesions, ECOG ≤2, expected survival ≥3 months, and able to consent and undergo PET/CT are ideal candidates.
Not a fit: Patients who are pregnant or breastfeeding, unable to tolerate PET/CT (severe claustrophobia), have intercurrent conditions making procedures unsafe, or are on VEGF TKI without an adequate washout may not benefit from participation.
Why it matters
Potential benefit: If successful, 68Ga-NYM096 PET/CT could improve detection and characterization of primary and metastatic tumors and help guide imaging-based clinical decisions.
How similar studies have performed: Gallium-68–labeled PET tracers have shown strong clinical utility in several cancers (for example PSMA and DOTATATE), but 68Ga-NYM096 itself is relatively new and is being characterized here.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 y 2. Histopathologically confirmed cancer (histopathologically proven primary tumors or metastases or radiologically unequivocal metastatic lesions of histologically proven primary tumors) 3. Expected survival of at least 3 months 4. ECOG ≤ 2 5. Written informed consent provided for participation in the trial 6. In the opinion of investigator, willing and able to comply with required study procedures. Exclusion Criteria: 1. On VEGF TKI treatment less than 1 week before 68Ga-NYM096 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NYM096. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM096 PET/CT is required. 2. Intercurrent medical condition that renders the patient ineligible for the procedures. 3. Pregnancy or breastfeeding. 4. Severe claustrophobia.
Where this trial is running
Beijing
- Peking Union Medical College Hospital, Beijing, Beijing 100730 — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Li Huo, MD
- Email: huoli@pumch.cn
- Phone: +86 18612672038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.