Renal Cell Cancer Clinical Trial
Official title:
Hyperpolarized 13C Pyruvate Metabolic MRI to Predict Renal Tumor Aggressiveness
This feasibility study will evaluate how well hyperpolarized 13C pyruvate magnetic resonance imaging (MRI) scan works in predicting tumor aggressiveness in participants with renal tumors. Hyperpolarized 13C pyruvate is a non-radioactive substance with potential usage in the diagnostic imaging of tumors. Hyperpolarized 13C pyruvate MRI may help doctors determine non-invasively whether a kidney tumor is a benign tumor or cancer, and if cancer, how aggressive it is. This may help doctors and participants with renal tumors in the future to make better treatment decisions.
PRIMARY OBJECTIVES: 1. To investigate the association between HP 13C pyruvate-to-lactate conversion (peak lactate/pyruvate ratio, lactate /pyruvate AUC (area under the curve), the apparent rate constant (kPL) and renal tumor histology (benign renal tumors versus RCCs) and grade (low vs high grade in cases of RCCs). SECONDARY OBJECTIVES: 1. To determine the reproducibility of HP 13C pyruvate MRI in participants who undergo an optional second HP 13C pyruvate MRI. 2. To investigate the association between HP 13 C pyruvate-to-lactate conversion and tumor growth rate in participants who are deemed clinically appropriate for active surveillance for their renal tumors. 3. To determine the safety of HP 13C pyruvate in renal tumor participants. EXPLORATORY OBJECTIVES: 1. To investigate the association between HP markers (peak lactate/pyruvate, lactate /pyruvate AUC, kPL) and tissue-based markers including Lactate Dehydrogenase A (LDHA) expression and lactate dehydrogenase (LDH) activity, and Monocarboxylate transporter 4 (MCT4) expression on tumor tissues from surgical specimen or from biopsy. 2. To explore the correlation between HP 13C pyruvate-to-lactate conversion (peak lactate/pyruvate ratio, lactate/pyruvate AUC (area under the curve), the apparent rate constant kPL) and 13C urea tissue perfusion in the kidneys and renal tumors. OUTLINE: Participants receive HP 13C pyruvate intravenously (IV) or a combination of co-polarized 13C pyruvate and 13C, 15N2 Labeled urea (15N2) and then undergo MRI scan 1-2 minutes post injection Participants may receive an optional second HP 13C pyruvate intravenously (IV) or a combination of hyperpolarized 13C pyruvate and 13C, 15N2 urea injection and undergo 13C pyruvate MRI scan 15 to 30 minutes following completion of the first scan during the same imaging session, or the participant can return for a separate visit within 1-2 weeks from the first MRI to receive the optional second scan. After completion of study treatment, participants are followed up 30 minutes. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01392729 -
An Observational Study of Avastin (Bevacizumab) and Interferon Alpha 2a in Patients With Metastatic Renal Cell Cancer (VERA)
|
N/A | |
Completed |
NCT00520403 -
A Study of Avastin (Bevacizumab) in Combination With Standard Therapy in Patients With Metastatic Renal Cell Cancer.
|
Phase 2 | |
Completed |
NCT00694096 -
Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response
|
Phase 1 | |
Completed |
NCT00216801 -
Relationship of Ochratoxin A to Upper Urologic Cancers
|
N/A | |
Completed |
NCT00172003 -
Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
|
Phase 4 | |
Completed |
NCT02493751 -
A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)
|
Phase 1 | |
Recruiting |
NCT01967407 -
IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.
|
Phase 1/Phase 2 | |
Completed |
NCT00509704 -
Influence of Sutent on Tumor Vascularization and Necrosis in Patients With Renal Cell Carcinoma
|
N/A | |
Terminated |
NCT05061537 -
Study of PF-07263689 in Participants With Selected Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT04535921 -
Fear of Cancer Recurrence in Genitourinary Cancer
|
||
Recruiting |
NCT04620603 -
Low-Dose-Rate Brachytherapy Combined With Immune Checkpoint Inhibition in Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT01829841 -
A Study of Famitinib in Patients With Advanced Metastatic Renal Cell Cancer
|
Phase 2 | |
Completed |
NCT01122615 -
Sunitinib Plus Temsirolimus in Patients With Renal Cell Cancer (RCC)
|
Phase 1 | |
Completed |
NCT00979329 -
Study on the Influence of Sunitinib and Sorafenib on Fatigue, QoL, Depression in Patients With Metastatic RCC or GIST
|
N/A | |
Active, not recruiting |
NCT02429440 -
Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides
|
Phase 1/Phase 2 | |
Recruiting |
NCT06362369 -
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02684006 -
A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101)
|
Phase 3 | |
Completed |
NCT02375776 -
Improving Outcomes in Cancer Patients on Oral Anti-Cancer Medications Using a Multi-modal Mobile Health Intervention
|
N/A | |
Completed |
NCT01598597 -
An Observational Pilot Study Evaluating the Feasibility of Conducting Genome-Wide Association Studies Utilizing Subject Provided Information in Subjects With Locally Recurrent or MBC, MCRC, MNSCLC, RGBM or MRCC Treated With Avastin (Bevacizumab) (InVite)
|
N/A | |
Completed |
NCT00465179 -
Sunitinib Malate in Patients With Non-Clear Cell Renal Cell Cancer
|
Phase 2 |