Using 68Ga-NY104 PET/CT to improve imaging in Von Hippel-Lindau Disease
68Ga-NY104 PET/CT and Conventional Imaging in Patients With Von Hippel-Lindau Disease: a Prospective, Single-center, Single-arm, Comparative Imaging Study
This study is testing a new imaging tool called 68Ga-NY104 PET/CT to see if it can better detect tumors in people with Von Hippel-Lindau disease compared to regular imaging methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | girentuximab, sunitinib, cabozantinib, lenvatinib |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05810246 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial evaluates the effectiveness of 68Ga-NY104 PET/CT as a diagnostic imaging tool for patients with Von Hippel-Lindau (VHL) disease. The study aims to determine the sensitivity of this novel PET tracer in detecting tumors associated with VHL, which may be missed by conventional imaging methods. By comparing the results of 68Ga-NY104 PET/CT with standard imaging, the trial seeks to assess its impact on patient management and treatment decisions. Additionally, the study will explore interobserver agreement in interpreting the imaging results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with Von Hippel-Lindau disease.
Not a fit: Patients currently undergoing VEGF TKI treatment may not benefit from this study due to potential interference with the imaging results.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of VHL-related tumors, enhancing patient management and outcomes.
How similar studies have performed: While this approach is novel in the context of VHL disease, similar imaging techniques have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosis of VHL disease, according to 2022 CSCO guideline, if any one of the following criteria is met: germline VHL alteration, family history of VHL syndrome as well as presence of at least one VHL related tumor (including hemangioblastoma, clear cell renal cell tumor, pheochromocytoma, paraganglioma, pancreatic neuroendocrine tumor, etc.), two or more hemangioblastoma, hemangioblastoma and pheochromocytoma, hemangioblastoma and clear cell renal cell tumor. 2. Age ≥ 18 y 3. Written informed consent provided for participation in the trial 4. In the opinion of investigator, willing and able to comply with required study procedures. Exclusion Criteria: 1. Patients on VEGF TKI treatment \< 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required. 2. Patients on HIF antagonist treatment \< 3 months before 68Ga-NY104 PET/CT. CA9, which encodes carbonic anhydrase IX (CAIX), is one of the genes most strongly upregulated by HIF-1. HIF antagonist, such as Belzutifan, might affect the expression of CAIX and thus the binding of 68Ga-NY104 to tumor. Withdraw of at least 3 months is required for HIF antagonist. 3. Patients with known allergic reaction to CT or MR contrast medium. 4. Patients with renal dysfunction 5. Pregnancy or breastfeeding. 6. Severe claustrophobia. 7. If the patient will undergo an exploratory 68Ga-NODGA-LM3 PET/CT and is on cold somatostatin analogue (such as Octreotide and Lanreotide), the 68Ga-NODGA-LM3 should be injected at least 24 hours after cold somatostatin analogue injection. Patients violating this criteria will not be able to attend the exploratory 68Ga-NODGA-LM3 PET/CT study but will still be considered eligible for the main study.
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Li Huo, MD — Peking Uion Medical College Hospital
- Study coordinator: Li Huo, MD
- Email: huoli@pumch.cn
- Phone: 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.