Using 68Ga-NY104 PET/CT to evaluate metastatic clear cell renal cell carcinoma
68Ga-NY104 PET/CT and 18F-FDG PET/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma: a Prospective, Single Center, Single Arm, Comparative Imaging Trial
This study is testing a new imaging method called 68Ga-NY104 PET/CT to see if it can better detect metastatic clear cell kidney cancer compared to a standard imaging method in patients with this condition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (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, Beijing) |
| Trial ID | NCT05879471 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial is designed to assess the sensitivity of 68Ga-NY104 PET/CT imaging in patients diagnosed with metastatic clear cell renal cell carcinoma. Participants will receive both 68Ga-NY104 and 18F-FDG via intravenous injection, followed by dedicated whole-body PET/CT imaging. The imaging results will be independently interpreted by two blinded readers to compare the effectiveness of both imaging modalities in detecting metastatic lesions. The study aims to recruit 39 patients at Peking Union Medical College Hospital.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of metastatic clear cell renal cell carcinoma and an expected survival of at least 6 months.
Not a fit: Patients currently undergoing treatment with VEGF TKIs or HIF antagonists may not benefit from this study due to potential interference with the imaging agent.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of imaging for metastatic clear cell renal cell carcinoma, leading to better treatment planning.
How similar studies have performed: While this approach is novel in the context of 68Ga-NY104, similar imaging studies have shown promise in enhancing detection rates for various cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 y 2. Histopathological diagnosis of clear cell renal cell carcinoma 3. Metastatic disease confirmed by histopathology or typical appearance of multifocal metastatic disease 4. Expected survival of at least 6 months 5. ECOG ≤ 2 6. Written informed consent provided for participation in the trial 7. 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-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. Pregnancy or breastfeeding. 4. Severe claustrophobia.
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.