Using PSMA PET/CT to improve imaging in metastatic clear cell kidney cancer
Comparison of [18F] PSMA-1007 PET/CT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma
This study is testing a new type of imaging called PSMA PET/CT to see if it can find hidden cancer spots in patients with metastatic clear cell kidney cancer who haven't started treatment yet.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Western University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06428708 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of [18F] PSMA-1007 PET/CT imaging in patients with metastatic clear cell renal cell carcinoma who have not yet received systemic therapy. It aims to identify additional metastatic sites that may not be visible through conventional imaging methods like CT or MRI. The study will involve a single institution and will require histologic confirmation of metastatic disease prior to participation. Approximately 26 new patients with this condition are seen annually at the institution, ensuring adequate recruitment over the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically-proven metastatic clear cell renal cell carcinoma.
Not a fit: Patients with non-clear cell histology or those requiring urgent cancer treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could lead to more accurate staging and better management options for patients with metastatic clear cell renal cell carcinoma.
How similar studies have performed: Other studies have shown promise in using PSMA-targeted imaging for various cancers, suggesting potential success for this novel approach in kidney cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men and women with histologically-proven, metastatic renal cell carcinoma (RCC)(TNM stage Tany, Nany, M1) 2. Must have baseline conventional imaging of the chest, abdomen, and pelvis with contrast-enhanced CT or MRI within 5 weeks of enrolment. Contrast is required unless the participant cannot for medical reasons (ie renal failure). Exception: Unenhanced CT of the chest is acceptable Exception: Unenhanced MRI of abdomen and pelvis is acceptable in cases of renal failure Exclusion Criteria: 1. Pregnant or breastfeeding 2. Age less than 18 3. Histology does not have any clear cell component 4. Unable to lie flat for 30 minutes for the scan 5. History of prior malignancy (except non-melanoma skin cancer) 6. Unable to provide informed consent 7. Inadequate liver function 8. Systemic or radiation-based cancer treatment is needed urgently and anticipated to begin before PSMA scan can take place 9. Previously exposed to systemic or radiation cancer therapy (except radiation for skin cancer)
Where this trial is running
London, Ontario
- London Health Sciences Centre - Victoria Hospital — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Melissa Huynh, MD — Western University
- Study coordinator: Kaydee Connors
- Email: kaydee.connors@lhsc.on.ca
- Phone: 519-685-8500
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.