Using 68Ga-NY104 PET/CT to detect clear cell renal cell carcinoma recurrence or metastasis
68Ga-NY104 PET/CT in Patients With Metastasis/Recurrence Clear Cell Renal Cell Carcinoma Suspicion: a Prospective, Single Center, Single Arm Imaging Trial
This study is testing a new type of imaging called 68Ga-NY104 PET/CT to see if it can help find signs of recurrence or spread of clear cell kidney cancer in patients who might have it.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (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 | NCT05879497 on ClinicalTrials.gov |
What this trial studies
This phase 2 clinical trial is designed to evaluate the effectiveness of 68Ga-NY104 PET/CT imaging in patients suspected of having metastasis or recurrence of clear cell renal cell carcinoma (ccRCC). The study will involve administering a single dose of 68Ga-NY104 to participants, followed by whole-body PET/CT imaging. Two independent readers will interpret the imaging results to assess the sensitivity and specificity of this diagnostic approach. A total of 40 patients will be recruited at Peking Union Medical College Hospital for this prospective, single-center study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of clear cell renal cell carcinoma and suspected metastasis or recurrence.
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 improve the accuracy of diagnosing metastasis or recurrence in patients with clear cell renal cell carcinoma.
How similar studies have performed: While the use of PET/CT imaging in oncology is well-established, the specific application of 68Ga-NY104 for ccRCC is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 y 2. Histopathological diagnosis of clear cell renal cell carcinoma 3. Suspected of metastasis or recurrence from ccRCC based on previous conventional imaging or 18F-FDG PET/CT scan. 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.