None listed
Conditions
Brief summary
This study is designed to investigate how a specialised PET/CT scan using 89Zr-girentuximab can assist in detecting and evaluating tumours that express a protein known as CA-IX. The goal is to determine how this scan compares with standard diagnostic approaches and whether it improves treatment planning for certain cancers. Who is it for? This research is suitable for adults aged 18 years and older with a suspected or confirmed diagnosis of clear cell renal cell carcinoma (ccRCC), mesothelioma, or another cancer type expected to express CA-IX. Participants must be medically stable, able to provide informed consent, and have an expected survival of more than three months. Study details Participants referred by their treating doctor will undergo a PET/CT scan using the imaging agent 89Zr-girentuximab at the Melbourne Theranostic Innovation Centre. All eligible participants will receive the scan as part of the study. Clinical teams will compare results from this scan with other routine imaging tests, biopsy results, and clinical outcomes over a 12-month period to assess its accuracy and usefulness. Additional follow-up will involve reviewing medical records and may include phone interviews to evaluate treatment decisions. It is hoped that the result from this study will demonstrate the clinical impact of girentuximab, highlighting its value in the management of patients with CAIX expressing tumours.
Interventions
This is a prospective, non-randomised study involving patients who will be identified by managing clinicians and referred to the Melbourne Theranostic Innovation Centre for imaging on the Siemens Biograph Vision Quadra for suspected or proven CA-IX-expressing tumours. Patient selection will involve accruing 100 suitable patients into the following three groups: • Group 1: 30 patients with a presumed or suspected primary diagnosis of ccRCC based on conventional imaging with ultrasound, CT or MRI, including up to 10 individuals with VHL mutation • Group 2: 20 patients with a presumed or proven diagnosis of mesothelioma • Group 3: 50 patients evaluated in the post-treatment setting for evaluation of residual mass lesions or assessment of therapeutic response with either ccRCC or mesothelioma or other cancers anticipated to have elevated CA-IX expression The pretest management decision based on all other available information (treatment intention) will be recorded prior to the PET scan. The actual treatment performed will be reviewed at 6 and 12 months after the scan. The accuracy of the PET scan will be ascertained from the results of other imaging studies, pathological and surgical findings and from clinical outcome including survival. Other correlative imaging studies performed within 2 weeks of the PET and without intervening procedures or treatment that may impact comparability of the scans, will be directly compared with the PET scan to assess the accuracy with which tumour detection is achieved by each modality.
Sponsors
Eligibility
Inclusion criteria
• Referred for an 89Zr-girentuximab PET/CT for clinical evaluation. • For evaluation of histologically proven or strongly suspected malignancy of one of the following types: o Clear cell renal cell carcinoma (ccRCC) o Mesothelioma o Other suspected solid tumour anticipated to express CA-IX • The patient must have a defined management plan provided by the referring clinician prior to performance of the PET scan. • The patient must be 18 or older. • Patient must be able to provide informed consent. • Expected survival >3 months. • ECOG status <4.
Exclusion criteria
• Is unable to understand or is unwilling to sign a written informed consent documents or to follow investigational procedures in the opinion of the investigator. • The patient is pregnant or breast feeding. • Patient is unable to lie supine at least 15 minutes while having the PET scan. • Has known allergies, hypersensitivity, or intolerance to the investigational drug or its excipients.