Imaging with 68Ga-NY104 for detecting renal cell carcinoma
68Ga-NY104 PET/CT Imaging in Patients With Confirmed or Suspicious Renal Cell Carcinoma
This study is testing a new imaging method using 68Ga-NY104 to see if it can better detect clear cell renal cell carcinoma in patients who are having surgery or have suspected recurrence of the disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05902377 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to evaluate the effectiveness of 68Ga-NY104 PET/CT imaging in identifying clear cell renal cell carcinoma (ccRCC) in patients. It will recruit two groups of participants: those scheduled for surgical removal of renal masses and those with confirmed or suspected recurrent ccRCC. Each participant will receive a single intravenous dose of 68Ga-NY104, followed by whole-body PET/CT imaging to assess the imaging's sensitivity and specificity. The study will be conducted at Peking Union Medical College Hospital, adhering to ethical guidelines and regulations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with renal masses scheduled for surgery or those with confirmed or suspected recurrent ccRCC.
Not a fit: Patients currently undergoing VEGF TKI treatment, pregnant or lactating women, and those with severe claustrophobia may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could improve the accuracy of diagnosing and monitoring renal cell carcinoma.
How similar studies have performed: While this approach is novel in the context of 68Ga-NY104 for renal cell carcinoma, similar imaging techniques have shown promise in other cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent provided for participation in the trial 2. Age ≥ 18 y 3. at least one of the following indications should be applied 1. Scheduled for surgical resection of renal mass 2. confirmed recurrent/metastatic clear cell renal cell carcinoma 3. suspicion for recurrent/metastatic clear cell renal cell carcinoma Exclusion Criteria: 1. On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. 2. Pregnancy or lactation 3. Severe claustrophobia.
Where this trial is running
Beijing, Beijing
- Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Huo Li, MD — Peking Uion Medical College Hospital
- Study coordinator: Huo Li, 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.