Evaluating a new PET imaging method for renal cell carcinoma
A Prospective, Open-label, Single-center Study of CD70-Specific PET/CT Imaging for Non-invasive Diagnosis of Renal Cell Carcinoma
This study is testing a new type of PET scan to see if it can better diagnose and stage kidney cancer in patients who are suspected of having the disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, China, Shaanxi) |
| Trial ID | NCT06769893 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the effectiveness of 68Ga-NOTA-RCCB6 PET imaging in diagnosing and staging renal cell carcinoma (RCC). It involves a prospective, open-label design with 60 patients suspected of having RCC, who will undergo PET/CT scans to evaluate the imaging protocol and diagnostic efficacy. The study will compare the results of this new imaging method with the established 68Ga-PSMA PET/CT imaging. The research includes a structured screening, baseline, and follow-up assessment period to ensure comprehensive data collection.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a high suspicion of renal cell carcinoma based on conventional imaging.
Not a fit: Patients who have received prior anti-tumor treatments or have severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing and staging renal cell carcinoma, leading to better-targeted therapies.
How similar studies have performed: While similar imaging techniques have been explored, this specific approach using 68Ga-NOTA-RCCB6 PET imaging is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- The subject or legal guardian/caregiver must voluntarily sign the informed consent form. Ages 18 to 75 years old. Patients with suspected renal cell carcinoma based on conventional imaging studies, and who undergo 68Ga-PSMA PET/CT scanning. Patients with suspicious lymph nodes or distant metastases detected by conventional imaging or 68Ga-PSMA PET/CT. Willing and able to follow the study protocol. Exclusion Criteria: \- Patients who have received anti-tumor treatment prior to PET/CT scan. Suffer from severe other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, respiratory system, immunodeficiency and other serious diseases. Alternative subjects have contraindications to PET/CT scanning. Including but not limited to: those who cannot tolerate repeated intravenous injections; those who may be allergic to the drug and its components (including those with a history of severe allergies or allergic reactions, especially those with allergies to the tested drug); claustrophobia. In the past year, diagnosed with other malignant tumors; alternative subjects have undergone major surgery in the past 3 months; received experimental drug or device treatment with unclear effects or safety within the past month, or have participated in other interventional clinical trials. Pregnant or lactating women. Patients who are lost to follow-up. Other conditions that, in the researcher's assessment, may affect the study or make the subject unsuitable for participation in the study.
Where this trial is running
Xi'an, China, Shaanxi
- Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China — Xi'an, China, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Ying Guo
- Email: guoying01192022@163.com
- Phone: 0086+15991459177
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.