Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT04258462

Rekrutierung

Hyperpolarized 13C Pyruvate MRI Scan in Predicting Tumor Aggressiveness in Patients With Renal Tumors

Interventionsstudie

Phase 2

University of California, San Francisco

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.

Detaillierte Beschreibung anzeigen

Behandlungskategorie

Andere Medikamente, Eingriff

Erforderliche Mutationen

Keine

Studie gestartet

2019-01-15

Zuletzt vom Sponsor aktualisiert

2025-10-24

Voraussichtlicher Abschluss

2026-12-31

Eignung

Einschlusskriterien

1. Renal tumor measuring 1 cm and greater in diameter. To minimize any potential partial volume effects in this pilot study, the investigators have limited the lower size range of the tumor to 1 cm. The investigators will include all renal tumor measuring 1 cm and greater in diameter in this first study to facilitate obtaining tumors of a range of histology and grade.

2. The participant is being considered by the treating physician to have any of the following management options: partial or radical nephrectomy, ablation, or active surveillance for his/her renal tumor.

3. The participant is able and willing to comply with study procedures and provide signed and dated informed consent.

4. The participant is willing to undergo standard of care abdominal MRI in connection with the study exam.

5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Ausschlusskriterien

2. Participants unwilling or unable to undergo magnetic resonance (MR) imaging, including patients with contra-indications to MR imaging, such as cardiac pacemakers or non-compatible intracranial vascular clips.

3. Any metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging of the abdomen.

4. Prior focal therapy (i.e. ablation) for the renal tumor.

5. Poorly controlled hypertension, with blood pressure at study entry >160/100. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.

6. Congestive heart failure or New York Heart Association (NYHA) status >= 2.

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Design-Details

ZuteilungNon-Randomized

InterventionsmodellSingle Group Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer100

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: Participants receive HP 13C pyruvate IV and then undergo 13C MRI scan 1-2 minutes post HP 13C pyruvate injection. Participants may receive an optional second HP 13C pyruvate injection and undergo 13C pyruvate MRI scan 15 to 30 minutes following completion of the first scan or at a return visit 1-2 weeks from the first HP C13 MRI

Interventionen:

Hyperpolarized Carbon C 13 Pyruvate
Magnetic Resonance Imaging
Hyperpolarized 13C,15N2-urea

Ergebnismessungen

Primäre Ergebnismessungen

Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the lactate /pyruvate area under curve (AUC) with tumor histology and grade.Up to 12 months

Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. We will use a tree-based cross-validated Classification & Regression Trees (CART) model for predicting benign renal tumors vs. low grade RCCs vs. high grade RCCs based on the HP 13C pyruvate metabolic data;

Comparison between HP 13C pyruvate-to-lactate conversion, as measured by peak lactate/pyruvate ratio with tumor histology and grade.Up to 12 months

Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. The investigators will use a tree-based cross-validated Classification & Regression Trees (CART) model for predicting benign renal tumors vs. low grade renal cell carcinoma (RCC) vs. high grade RCCs based on the HP 13C pyruvate metabolic data

Comparison between HP 13C pyruvate-to-lactate conversion, as measured by the apparent rate of constant metabolic flux of HP 13C-pyruvate to lactate (kPL), with tumor histology and grade.Up to 12 months

Descriptive statistics (mean, median, standard deviation, distribution, etc) of the metabolism measures will be calculated. The investigators will use a tree-based cross-validated Classification & Regression Trees (CART) model for predicting benign renal tumors vs. low grade RCCs vs. high grade RCCs based on the HP 13C pyruvate metabolic data;

Sekundäre Ergebnismessungen

Incidence of treatment-related adverse events1 day, 30 minutes following hyperpolarized 13C pyruvate injection

Assessment of the occurrence of clinically significant changes in safety variables from baseline. Safety endpoints include monitoring for the occurrence of treatment-emergent AEs. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology (Toxicity) Criteria for Adverse Events (CTCAE) version 4.0.

Estimate of intra-subject agreement for those with optional second scanUp to 12 months

For participants who obtained an optional second HP 13 C pyruvate magnetic resonance imaging (MRI), intraclass correlation coefficient (ICC) will be used to estimate the intra-subject agreement. ICCs will be obtained from a one-way analysis of variance model based on 2 serial measurements per subject. The ICC ranges from 0 to 1. An ICC close to 1 indicates high similarity between values from the same group. An ICC close to zero means that values from the same group are not similar. The results will be presented with a 95% confidence interval.

Comparison of the HP 13C metabolism measures to change in tumor sizeUp to 12 months

For participants who are in active surveillance for their renal tumors, MRI findings will be compared to tumor growth rate while on active surveillance. Correlations of HP 13C metabolism measures to change in tumor size on subsequent surveillance imaging studies will be performed using Pearson or rank correlation.

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Studienzentren

Diese Studie hat 1 Studienzentrum

University of California, San Francisco
San Francisco, California, US

Rekrutierend

San Francisco, California, 94143 US

University of California, San Francisco

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