Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Participants With Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/13/2019 |
| Start Date: | February 6, 2019 |
| End Date: | July 31, 2019 |
| Contact: | Vikas Kundra, MD |
| Email: | vkundra@mdanderson.org |
| Phone: | 713-745-2702 |
Hyperpolarized 13-C-Pyruvate Magnetic Resonance Spectroscopic Imaging Reproducibility Pilot in Patients With Prostate Cancer
The goal of this clinical research study is to learn if performing an MRI using an imaging
agent called hyperpolarized 13-C-pyruvate can be reproduced to an acceptable degree that will
allow for further study.
Researchers are hoping that this new agent will help to accurately predict how prostate
cancer patients will respond to standard therapy (abiraterone and apalutamide).
An imaging agent is like a contrast agent and may help researchers see the imaging scans more
clearly.
This is an investigational study. Hyperpolarized 13-C-pyruvate is not FDA approved or
commercially available. Its use in this study is investigational. The study doctor can
describe how hyperpolarized 13-C-pyruvate is designed to work.
Up to 10 participants will be enrolled in the study. All will take part at MD Anderson.
agent called hyperpolarized 13-C-pyruvate can be reproduced to an acceptable degree that will
allow for further study.
Researchers are hoping that this new agent will help to accurately predict how prostate
cancer patients will respond to standard therapy (abiraterone and apalutamide).
An imaging agent is like a contrast agent and may help researchers see the imaging scans more
clearly.
This is an investigational study. Hyperpolarized 13-C-pyruvate is not FDA approved or
commercially available. Its use in this study is investigational. The study doctor can
describe how hyperpolarized 13-C-pyruvate is designed to work.
Up to 10 participants will be enrolled in the study. All will take part at MD Anderson.
PRIMARY OBJECTIVES:
I. To assess reproducibility of quantitative spectroscopic and imaging parameters in
hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including key
performance indicator (kpl), which assesses the rate of conversion of 13-C pyruvate to 13-C
lactate in the tissue of interest, using a test-retest study design.
SECONDARY OBJECTIVES:
I. To provide initial assessment of the sensitivity and specificity of hyperpolarized
13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer.
OUTLINE:
Participants receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20
seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
After completion of study, participants are followed up at 1 day and then for up to 3 years.
I. To assess reproducibility of quantitative spectroscopic and imaging parameters in
hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including key
performance indicator (kpl), which assesses the rate of conversion of 13-C pyruvate to 13-C
lactate in the tissue of interest, using a test-retest study design.
SECONDARY OBJECTIVES:
I. To provide initial assessment of the sensitivity and specificity of hyperpolarized
13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer.
OUTLINE:
Participants receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20
seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.
After completion of study, participants are followed up at 1 day and then for up to 3 years.
Inclusion Criteria:
1. Biopsy proven high risk prostate adenocarcinoma
2. Gleason >/= 8 OR Gleason 7 +>/=cT2b+PSA>10ng/ml
3. Patients enrolled in 2016-0527 under IND 136,288; PI, Efstathiou. Imaging for the
current study (2017-0403) will be completed prior to randomization and initiation of
study drug on 2016-0527. Patient who have initiated Lhrh analog or antagonist within
the past 4 weeks are eligible.
4. Prior prostate biopsy must have been performed at least 5 weeks prior
Exclusion Criteria:
1. Contraindication to MRI
2. eGFR<30
3. Allergy to gadavist intravenous contrast
4. History of cardiac arrhythmia
5. Since they do not get prostate cancer, women are excluded; thus, pregnancy is not an
issue.
We found this trial at
1
site
Houston, Texas 77030
Principal Investigator: Vikas Kundra
Phone: 713-745-2702
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