과분극된 13C-피루브산 대사 자기 공명 영상의 유용성

실험적: 전립선암이 의심되거나 알려진 환자에 대한 단일군 연구

전립선암이 의심되는 남성에게 대사 자기공명영상을 실시하여 이 모집단에서 대사 MRI를 안전하게 수행할 수 있는지 확인합니다.

의약품: 과분극화 13C-피루브산

스핀 편광("과분극") [ 13C]피루베이트를 함유하는 과분극 피루베이트(13C) 주입은 13C 분광 MR 영상과 함께 진단제로 연구되고 있습니다. 목표는 [13C]피루브산과 그 대사산물을 시각화하여 정상 대 비정상 신진대사가 있는 해부학적 영역을 구별하는 것입니다. 이는 예를 들어 악성 종양을 진단하고 특성화하는 데 유용해야 합니다.

Hyperpolarized Pyruvate (13C) 주입 및 [13C]피루베이트는 이 책자 전체에서 사용되는 일반 용어이며 [1-13C]피루베이트, [2-13C]피루베이트 및 [1,2-13C]와 같은 모든 13C 라벨링 패턴을 나타냅니다. 피루브산. 생물학적 및 안전성 관점에서 각 표지 패턴을 가진 피루브산은 인체에서 동일하게 작용합니다[Koletzko et al., 1997].

CTCAE v4.0 Higher Than Grade 2

Quantify the number of participants who get this scan and have treatment-related adverse events as assessed by CTCAE v4.0 higher than grade 2. Determine the number of participants who successfully complete a scan which meets a minimum quality standard as measured by signal to noise ratio on the scan, hyperpolarized metabolic MRI in the diagnosis of prostate cancer.

Accuracy of Metabolic MRI to Diagnose Prostate Cancer

To study the accuracy of hyperpolarized metabolic MRI to diagnose prostate cancer. Compare the prediction of cancer from the MRI scan compared to actual diagnosis of cancer by any subsequent workup or procedure the participant undergoes. Prediction of cancer from MRI scan will be performed by assigning a standardized score (PIRADS v2.0). Actual diagnosis of cancer will be based on tissue pathology (with cancer grade characterized using the prostate cancer ISUP Grade Group system) from any procedure the patient undergoes.

Utility of Metabolic MRI Over Standard MRI Imaging in the Diagnosis of Prostate Cancer

To examine the added utility of metabolic MRI over standard MRI imaging. Quantify the number of participants in which the MRI provided extra information that otherwise was not available during the course of the patient's workup.

Correlative Metabolic Analysis of Tissue Metabolite Concentrations Versus Cancer Diagnosis

To perform correlative metabolic analysis related to cancer diagnosis. Using the research tissue when it is available. Analyze tumor samples when available from participants and characterize the metabolite concentration (microgram/mg of tissue) within the tumor to determine how the concentration value compares to two outcomes of interest: 1: the numerical suspicion score (PIRADS v2.0 system) from the imaging from the patient and 2: The presence of cancer and grade of cancer (ISUP Grade Group system), when present, from pathology analysis performed on the tissue from the patient available. Analyze tumor samples when available from participants and characterize the metabolite concentration within the tumor to determine how this compares to the information from the imaging from the patient and pathology analysis performed on the tissue