Renal Cell Carcinoma

Researchers are evaluating the use of 3D ultrasound imaging to guide standard care procedures such as ablation or biopsies of liver or kidney tumours. This observational study compares 3D ultrasound with conventional 2D ultrasound and checks the imaging results against pre- and post-procedure CT scans to assess how well tumours are removed or targeted during biopsies. The 3D ultrasound method uses a special assembly to move the ultrasound transducer in precise steps, creating detailed 3-dimensional images from multiple 2D images. During the study, patients undergoing liver or kidney tumour ablation or biopsy will be imaged using both standard care and 3D ultrasound devices. These devices record image data passively while the medical procedures are performed. The 3D ultrasound images are processed with specialized software to create volumes that allow viewing the area of interest from different angles. This imaging will be compared with CT images to verify the accuracy of tumour removal or biopsy targeting. Participants will be imaged by physicians during their scheduled ablation or biopsy procedures. The study involves collecting ultrasound image data during the treatment and analyzing these images afterward. Researchers will review the guidance and targeting accuracy of the needles used during these procedures as the primary outcome. The study is conducted by Western University, Canada, and patients who are well enough to consent and undergoing these standard care procedures are eligible to participate.

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PET/CT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PET/CT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PET/CT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PET/CT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

Researchers are evaluating the use of a radiotracer called 64Cu-GRIP B with PET imaging to detect granzyme B, a biomarker produced by immune cells during immunotherapy, in patients with advanced cancers that have spread to nearby tissues or lymph nodes. This phase I/II study focuses on genitourinary cancers, including renal cell carcinoma, urothelial cancer, and metastatic castration-resistant prostate cancer, aiming to assess safety and usefulness of the imaging in monitoring immune response. Participants are divided into four groups based on cancer type: metastatic genitourinary malignancies, renal cell and urothelial carcinoma, metastatic castration-resistant prostate cancer, and other solid tumors. All receive the 64Cu-GRIP B injection followed by PET scans at baseline. Some groups have additional scans at 8 weeks and at disease progression. Imaging methods include PET/CT or PET/MRI, with safety monitoring conducted at multiple time points after tracer injection. During the study, patients undergo scans, blood sampling, and tumor biopsies when applicable. Researchers monitor adverse events, tracer distribution, and tumor uptake patterns over time. Outcomes measured include safety, tracer pharmacokinetics, changes in tumor uptake values, and correlations with clinical outcomes such as response to immunotherapy and progression-free survival. Participants are followed for up to two years to assess long-term effects and disease progression.

This research aims to assess the diagnostic value of a new PET/CT imaging probe called 68Ga-C1, which specifically targets the CAIX protein found in about 95% of clear cell renal cell carcinomas. The study will also investigate the safety, tolerability, and radiation exposure from 68Ga-C1. Researchers will compare this new imaging method with the standard 18F-FDG PET/CT scan in Chinese patients who have unclear kidney masses or confirmed clear cell renal cell carcinoma. Participants with suspected or confirmed clear cell renal cell carcinoma will receive an intravenous injection of 68Ga-C1 at a dose of 0.05-0.10 mCi/kg, followed by PET imaging. They will also undergo a whole-body 18F-FDG PET/CT scan within one week. This approach allows direct comparison of the two imaging techniques in the same patients. During the study, participants will have PET/CT scans with both imaging agents to evaluate tumor detection and characteristics. Researchers will measure diagnostic accuracy, radiation dosimetry, and quantitative uptake of 68Ga-C1 over one year. Correlation with tumor pathology will also be assessed. The study will monitor safety and tolerability throughout, with the overall participation lasting at least one year.

Researchers are evaluating the combination of 68Ga-NY104 and 18F-FDG PET/CT guided radiation therapy with standard systemic treatment in patients who have metastatic clear cell renal cell carcinoma (ccRCC). This phase 2 study focuses on improving treatment outcomes by targeting metastatic lesions more precisely using advanced imaging techniques. The biomarker CAIX, targeted by 68Ga-NY104, has shown promise in detecting ccRCC lesions effectively. Participants will receive radiation therapy planned to cover as many metastatic lesions as possible, guided by baseline PET/CT scans using both 68Ga-NY104 and 18F-FDG. Systemic therapy, which may include targeted therapy, immunotherapy, or both, will be given concurrently and determined by the treating urology oncologist. Follow-up 68Ga-NY104 PET/CT scans will be done at 6, 12, and 24 months if the tumor is controlled, with additional scans as needed for suspected recurrence. During the study, patients will undergo multiple PET/CT scans and other imaging to assess lesion uptake and detection. Researchers will monitor progression-free survival, disease control, overall survival, and adverse events over four years after treatment starts. The study tracks tumor response and safety outcomes while patients continue systemic therapy, with active follow-up for disease status and imaging assessments throughout the trial period.

Researchers are evaluating the diagnostic effectiveness of 68Ga-PSMA PET scans compared to enhanced CT scans in detecting metastatic lesions in patients with locally advanced and advanced renal cell carcinoma. The study also aims to see if 68Ga-PSMA PET can influence treatment decisions for these patients. This prospective, multicenter trial is sponsored by Xijing Hospital and focuses on improving diagnosis and management for renal cancer with metastases. Participants in the study will receive both a 68Ga-PSMA PET scan and an enhanced CT scan simultaneously to compare their abilities to detect cancer spread. This diagnostic approach helps assess the additional value that 68Ga-PSMA PET may provide over standard CT imaging. The study does not involve any masking or placebo groups and includes only patients who meet specific clinical and imaging criteria. During the study, patients will undergo imaging within six weeks after diagnosis, and researchers will track how the 68Ga-PSMA PET results affect treatment choices. The primary measurement is the additional diagnostic value of the PSMA PET compared to CT over two years. Secondary outcomes include how often the PET scan changes treatment decisions. The study monitors patient safety and adherence, with a planned follow-up period to evaluate outcomes until December 2027.

Researchers are studying 89Zr-TLX250, a diagnostic imaging agent, to detect clear cell renal cell carcinoma (ccRCC) in Chinese patients with indeterminate renal masses. This Phase 3, open-label, single-arm study aims to confirm the safety, tolerability, sensitivity, and specificity of 89Zr-TLX250 PET/CT imaging. The study supports prior ZIRCON trial data and involves adult patients scheduled for partial or total nephrectomy as part of their standard care. Participants will receive a single intravenous dose of 37 MBq of 89Zr-TLX250 containing 10 mg of girentuximab. Imaging of the abdomen using PET/CT will be performed 5 days post-administration, with possible whole-body imaging if widespread disease is suspected. Nephrectomy will occur any time after imaging but within 90 days. Histological analysis of tumor samples will confirm diagnosis. The study includes approximately seven visits over 4 to 6 months. Assessments include baseline exams, PET/CT imaging, surgery, and follow-up visits. Imaging and histological data will be centrally analyzed to evaluate diagnostic accuracy. Safety and tolerability will be monitored throughout. The study is expected to last about 12 months with 4 months of follow-up per participant.

Researchers are evaluating the use of a new imaging technique called [18F] PSMA-1007 PET/CT to detect metastatic clear cell renal cell carcinoma, a type of kidney cancer. This study focuses on patients 18 years or older who have metastatic clear cell kidney cancer and have not yet received systemic therapy. The goal is to see if this PET imaging can identify additional metastatic sites that conventional CT or MRI scans might miss, potentially changing how the disease is managed. All participants will undergo a single [18F] PSMA-1007 PET/CT scan to evaluate metastatic cancer lesions. This is a prospective, open-label study conducted at a single institution. Participants must have baseline conventional imaging of the chest, abdomen, and pelvis within 5 weeks before enrollment. The study will compare the PET/CT results to those of conventional imaging to assess the number of metastatic lesions and any changes in treatment plans. During the study, participants will have their imaging results reviewed, and any necessary histologic confirmation by biopsy will be performed if metastatic disease is found on conventional imaging. Researchers will monitor the number of detected metastatic lesions and any changes in patient management within one month. Pathologic correlates will also be assessed when applicable. The study expects to follow patients until September 2025, with careful safety and outcome monitoring throughout the process.

This research aims to evaluate the use of an investigational imaging agent called [18F]PT2385 in patients with renal cell carcinoma (RCC), including clear cell RCC and those with Von Hippel-Lindau (VHL) syndrome. The study is designed to explore how well this imaging method can measure levels of a protein called hypoxia-inducible factor-2alpha (HIF2b1) in tumors, which is important for understanding the disease. It is an open-label, non-therapeutic trial involving three patient groups with different disease presentations. Participants will receive an intravenous injection of [18F]PT2385 followed by PET/CT or PET/MRI scans to observe the distribution and uptake of the tracer in tumors. The first group consists of patients scheduled for surgery, who will have imaging before nephrectomy, with results compared to tissue analysis after surgery. The second group includes patients with metastatic clear cell RCC, who will have imaging and a mandatory biopsy of metastatic sites. The third group involves patients with VHL syndrome and various tumors, who will undergo imaging and are encouraged, but not required, to have a biopsy. Some participants may have repeat imaging after initial dosimetry assessments. Throughout the study, patients will undergo multiple imaging sessions, including dynamic and whole-body scans at different time points after tracer injection to analyze tracer kinetics and distribution. Researchers will collect tissue samples for comparison with imaging findings, and participants will continue with standard or experimental treatments as advised by their doctors. The study aims to correlate imaging results with tissue levels of HIF2b1 over up to five years, monitoring safety and feasibility during the process.