Clinical trial · Interventional
Imaging Studies of Kidney Cancer Using 18F-VM4-037
PET Imaging Of Renal Cell Carcinoma With 18F-VM4-037: A Phase II Pilot Study For Detection Of Disease And Correlation With VHL Mutation Status
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was closed to accrual because imaging agent was no longer available.
Summary
Brief summary (as posted)
Background: \- The drug 18F-VM4-037 is being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans. Researchers want to see how well it works for scans for people who have kidney cancer. Objectives: \- To test the safety and effectiveness of 18F-VM4-037 during imaging studies of kidney cancer. Eligibility: \- Adults at least 18 years of age with kidney cancer that will be treated with surgery. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will have two positron emission tomography (PET) scans of their kidneys. They will have the scans before and after receiving an injection of 18F-VM4-037. The scans will take about 2 hours to complete. * About 3 weeks after the PET scans, participants will provide tumor tissue samples from their kidneys. * This is a scanning study only. Treatment will not be provided as part of this study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-VM4-037 | Drug | — | UNRESOLVED |
| PET/CT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Renal Cell Carcinoma
- interventionNames
- Drug: 18F-VM4-037
- Procedure: PET/CT
Primary outcomes (1)
- measure
- Level of Uptake of 18F-VM4-037 in Tumor and Non Tumor Tissues, Calculated as Standardized Uptake Values (SUVs)
- timeFrame
- 58 days
- description
- The primary outcome measure will be assessed from quantitative measurements (e.g., correlate immunohistochemistry (IHC) results with standardized uptake values (SUVs) from positron emission tomography (PET) images) of the level of uptake of tumor and non tumor tissues into each target lesion, calculated as standardized uptake values. Normal renal parenchyma and muscle are both "non-tumor" tissue.
Secondary outcomes (8)
- measure
- Number of Participants With Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* INCLUSION CRITERIA: * Subject is greater than or equal to18 years old. * Subject must be scheduled to undergo surgery or biopsy for primary renal cell carcinoma (RCC) greater than or equal to 2.5cm in diameter or extrarenal/extrahepatic metastatic RCC lesion (greater than or equal to1cm in diameter) at the National Institutes of Health (NIH) Clinical Center based on imaging within 3 weeks. * Chemistry parameters: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2 times of the upper limits of normal; total bilirubin, of \< 2 times the upper limits of normal or \< 3.0 mg/dl in patients with Gilberts syndrome. * Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2. * Ability to provide informed consent. All subjects must sign an informed consent form indicating their understanding of the investigational nature and risks of the study before any protocol-related studies are performed. * The subject has a clinically acceptable medical history, physical examination and vital signs findings during the screening period (from within 21 days before administration of 18F-VM4-037). Components of an acceptable medical history include no active infection at the time of enrollment or within 7 days of enrollment, no prior therapy that results in immunocompromise or impaired renal function (serum creatinine within 2 weeks prior to positron emission tomography (PET) imaging less than or equal to1.8 mg/dl and epidermal growth factor receptor (eGFR) must be \> 30 ml/min/1.73m\^2) or findings indicating an inability to tolerate the requirements for the scan. Previous exposure to immunocompromising therapy does not exclude the patient; patients must have an absolute neutrophil count \> 1.5/microL within 2 weeks of PET imaging. * If female, must have a negative serum human chorionic gonadotropin (HCG) within 24 hours prior to 18F-VM4-037 injection OR be post menopausal for \> 2 years OR be surgically sterile. EXCLUSION CRITERIA: * Subjects for whom participating would significantly delay the scheduled standard of care therapy. * Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results. * Subjects with severe claustrophobia unresponsive to oral anxiolytics. * Other medical conditions deemed by the principle investigator (or associates) or sponsor to make the subject ineligible for protocol procedures. * Female subject is pregnant or nursing * The site of the target lesion must not have been part of a radiation portal within 6 months of enrollment. * Subjects having received another investigational agent within 1 month before administration of 18F-VM4-037.
References
Publications (4)
- BACKGROUNDJemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8. PMID 14974761
- BACKGROUNDLatif F, Tory K, Gnarra J, Yao M, Duh FM, Orcutt ML, Stackhouse T, Kuzmin I, Modi W, Geil L, et al. Identification of the von Hippel-Lindau disease tumor suppressor gene. Science. 1993 May 28;260(5112):1317-20. doi: 10.1126/science.8493574. PMID 8493574
- BACKGROUNDSeizinger BR, Rouleau GA, Ozelius LJ, Lane AH, Farmer GE, Lamiell JM, Haines J, Yuen JW, Collins D, Majoor-Krakauer D, et al. Von Hippel-Lindau disease maps to the region of chromosome 3 associated with renal cell carcinoma. Nature. 1988 Mar 17;332(6161):268-9. doi: 10.1038/332268a0. PMID 2894613
- RESULTTurkbey B, Lindenberg ML, Adler S, Kurdziel KA, McKinney YL, Weaver J, Vocke CD, Anver M, Bratslavsky G, Eclarinal P, Kwarteng G, Lin FI, Yaqub-Ogun N, Merino MJ, Linehan WM, Choyke PL, Metwalli AR. PET/CT imaging of renal cell carcinoma with (18)F-VM4-037: a phase II pilot study. Abdom Radiol (NY). 2016 Jan;41(1):109-18. doi: 10.1007/s00261-015-0599-1. PMID 26830617