Using 68Ga-NY104 PET/CT to detect clear cell renal cell carcinoma before surgery
68Ga-NY104 PET/CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Renal Masses
This study is testing a new imaging method called 68Ga-NY104 PET/CT to see if it can better detect clear cell kidney cancer in patients before they have surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (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 | NCT05879510 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 detecting clear cell renal cell carcinoma in patients with renal masses who are scheduled for surgical resection. Participants will receive an intravenous dose of 68Ga-NY104, followed by whole-body PET/CT imaging and contrast-enhanced CT imaging of the abdomen. The study aims to compare the sensitivity and specificity of these imaging modalities against histopathological diagnoses. A total of 63 patients will be recruited at Peking Union Medical College Hospital, and the results will help determine the diagnostic accuracy of 68Ga-NY104 PET/CT.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a renal mass who are scheduled for surgical resection.
Not a fit: Patients currently on VEGF TKI treatment or those with conditions preventing surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing clear cell renal cell carcinoma, leading to better treatment planning for patients.
How similar studies have performed: While the use of PET/CT imaging in cancer detection is established, the specific application of 68Ga-NY104 for clear cell renal cell carcinoma 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. Presence of a renal mass 3. Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique) 4. Expected survival of at least 3 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. Intercurrent medical condition that renders the patient ineligible for surgery. 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.