Clinical trial · Interventional
[18F] PSMA-1007 PET/CT in Metastatic Clear Cell Renal Cell Carcinoma
Comparison of [18F] PSMA-1007 PET/CT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F] PSMA-1007 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F] PSMA-1007 PET/CT
- description
- All patients enrolled undergo a \[18F\] PSMA-1007 PET/CT
- interventionNames
- Diagnostic Test: [18F] PSMA-1007 PET/CT
Primary outcomes (2)
- measure
- Number of metastatic lesions
- timeFrame
- 5 weeks from initial baseline conventional imaging
- description
- To identify additional metastatic lesions that may not be apparent on conventional cross-sectional imaging during the initial staging process.
- measure
- Change in management
- timeFrame
- 1 month
- description
- To determine the proportion of patients in which results from the PSMA-PET imaging changes management.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (14)
- BACKGROUNDMittlmeier LM, Unterrainer M, Rodler S, Todica A, Albert NL, Burgard C, Cyran CC, Kunz WG, Ricke J, Bartenstein P, Stief CG, Ilhan H, Staehler M. 18F-PSMA-1007 PET/CT for response assessment in patients with metastatic renal cell carcinoma undergoing tyrosine kinase or checkpoint inhibitor therapy: preliminary results. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):2031-2037. doi: 10.1007/s00259-020-05165-3. Epub 2020 Dec 28. PMID 33369689
- BACKGROUNDGiesel FL, Hadaschik B, Cardinale J, Radtke J, Vinsensia M, Lehnert W, Kesch C, Tolstov Y, Singer S, Grabe N, Duensing S, Schafer M, Neels OC, Mier W, Haberkorn U, Kopka K, Kratochwil C. F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):678-688. doi: 10.1007/s00259-016-3573-4. Epub 2016 Nov 26. PMID 27889802
- BACKGROUNDRhee H, Blazak J, Tham CM, Ng KL, Shepherd B, Lawson M, Preston J, Vela I, Thomas P, Wood S. Pilot study: use of gallium-68 PSMA PET for detection of metastatic lesions in patients with renal tumour. EJNMMI Res. 2016 Dec;6(1):76. doi: 10.1186/s13550-016-0231-6. Epub 2016 Oct 22. PMID 27771904
- BACKGROUNDYin Y, Campbell SP, Markowski MC, Pierorazio PM, Pomper MG, Allaf ME, Rowe SP, Gorin MA. Inconsistent Detection of Sites of Metastatic Non-Clear Cell Renal Cell Carcinoma with PSMA-Targeted [18F]DCFPyL PET/CT. Mol Imaging Biol. 2019 Jun;21(3):567-573. doi: 10.1007/s11307-018-1271-2. PMID 30218388
- BACKGROUNDMeyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30. PMID 31147927
- BACKGROUNDBaccala A, Sercia L, Li J, Heston W, Zhou M. Expression of prostate-specific membrane antigen in tumor-associated neovasculature of renal neoplasms. Urology. 2007 Aug;70(2):385-90. doi: 10.1016/j.urology.2007.03.025.