Evaluating 68Ga-PSMA PET for advanced renal cancer diagnosis
A Prospective, Multicenter Study of Diagnostic Efficiency of 68Ga-PSMA PET in the Patients With Locally Advanced and Advanced Renal Cell Carcinoma
This study is testing if a special imaging technique called 68Ga-PSMA PET can better find advanced kidney cancer spots compared to regular CT scans and see if it helps doctors make better treatment choices for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 9 sites (Lanzhou, Gansu and 8 other locations) |
| Trial ID | NCT04987086 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the diagnostic effectiveness of 68Ga-PSMA PET imaging in identifying metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. It will compare the results of PSMA PET with those obtained from enhanced CT scans. Additionally, the study will investigate whether the use of 68Ga-PSMA PET can influence treatment decisions for these patients. Participants will undergo imaging within six weeks of their diagnosis to ensure timely evaluation.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with locally advanced or advanced renal cell carcinoma who have suspicious metastases identified through contrast-enhanced CT.
Not a fit: Patients under 18 years old or those with contraindications for 68Ga PSMA ligands will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic accuracy and better treatment decisions for patients with advanced renal cancer.
How similar studies have performed: While the use of PSMA PET imaging has shown promise in other cancers, this specific application in renal cell carcinoma is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 2017 AJCC renal cell carcinoma TNM stage III, IV lesions; * In contrast-enhanced CT staging, suspicious metastases were found; * There were no known peripheral or central venous problems; * 68Ga PSMA PET / CT imaging can be performed within 6 weeks after the diagnosis of renal cell carcinoma; * Signed the informed consent form of voluntary participation in clinical trials. Exclusion Criteria: * Age ≤ 18 years old; * Can't stand lying flat in PET / CT examination; * There are contraindications for 68Ga PSMA ligands; * In the past two years, there was a history of other malignant tumors, or according to the doctor's research judgment, complications may occur and affect the normal operation of the test; * Renal function is impaired or hemodialysis is in progress.
Where this trial is running
Lanzhou, Gansu and 8 other locations
- The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)
- General Hospital of Ningxia Medical University — Yinchuan, Ningxia, China (Recruiting)
- Qinghai University Affiliated Hospital — Xining, Qinghai, China (Recruiting)
- Xijing Hospital — Xi'an, Shaan'xi, China (Recruiting)
- Weinan Central Hospital — Weinan, Shaanxi, China (Recruiting)
- Shaanxi Provincial People's Hospital — Xi'an, Shaanxi, China (Recruiting)
- Xijing 986 Hospital — Xi'an, Shaanxi, China (Recruiting)
- The Second Affiliated Hospital of Shaanxi University of Chinese Medicine — Xianyang, Shaanxi, China (Recruiting)
- Affiliated Hospital of Yan'an University — Yan’an, Shaanxi, China (Recruiting)
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.