Hyperpolarized Carbon-13 Imaging of Metastatic Prostate Cancer

NCT02844647 | Terminated Phase 1

• 1 other identifier: 432-2015
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

A pilot study with a group of up to 10 men with CRPC about to embark on a 6-month course of treatment with radium 223. Study participants will undergo anatomical MR imaging combined with the new hyperpolarized MRI (1 hour exam) prior to treatment.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Images of lactate, bicarbonate and pyruvate in patients with bone-metastatic CRPC measured by MRI

  1 year

Study Arms (1)

MRI w/ Hyperpolarized Pyruvate (13C)

EXPERIMENTAL

"Hyperpolarization" of low natural abundance species such as 13C, when injected offers the potential of extracting metabolic information by real-time MR imaging of biochemical reactions within the body. The biochemical reactions, including lactate production, will be measured using MRI.

Other: Hyperpolarized Pyruvate (13C)

Interventions

Hyperpolarized Pyruvate (13C) OTHER

MRI contrast agent

MRI w/ Hyperpolarized Pyruvate (13C)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with bone-metastatic CRPC before starting the first dose of radium 223 therapy
• Laboratory requirements:
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• Platelet count ≥ 100 x109/L
• Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
• Total bilirubin level ≤ 1.5 institutional upper limit of normal (ULN)
• ASAT and ALAT ≤ 2.5 ULN
• Creatinine ≤ 1.5 ULN
• Albumin \>25 g/L
• Eastern Cooperative Oncology Group Status of 0 or 1

You may not qualify if:

• Unable to give valid informed consent
• Contraindication for MRI as per Sunnybrook MRI questionnaire (Appendix 1).
• Claustrophobia
• Body mass index of less than 18.5 or greater than 32
• Congestive heart failure, a past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, which may include QT prolongation, a family history of prolonged QT interval syndrome, or a myocardial infarction (MI) within the past 12 months with ensuing unstable EKG, or ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Charles Cunningham, PhD

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: July 26, 2016
• Study Start: December 15, 2016
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: March 28, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)