Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851365
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2023-05-01
Brief Title:
Magnetic Resonance MR Imaging With Hyperpolarized Bicarbonate 13C to Measure Tissue pH in Prostate Cancer
Sponsor:
Robert Flavell MD PhD
Organization:
University of California San Francisco
Study Overview
Official Title:
A Pilot Study of Magnetic Resonance MR Imaging With Hyperpolarized Bicarbonate 13C to Measure Tissue pH in Localized Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single site prospective pilot study to determine the feasibility and safety of the administration of HP 13C bicarbonate in 10 patients with prostate cancer to determine potential hydrogen pH values in surrounding tissue The proposed study will evaluate pre-surgical participants with histologically confirmed localized prostate cancer who receive infusion of hyperpolarized 13C injection prior to MR imaging with endorectal coil
Detailed Description:
PRIMARY OBJECTIVE
I To determine the feasibility of tumor pH measurement in men with prostate cancer using hyperpolarized 13C bicarbonate imaging
SECONDARY OBJECTIVE
I To determine the safety of administration of hyperpolarized 13C-bicarbonate
EXPLORATORY OBJECTIVES
I To correlate the measurement of tissue pH with pathologic grade
II To correlate tissue pH maps with immunohistochemistry staining IHC gene expression RNA-Seq and spatial transcriptomics Bristol Myers Squibb BMS collaboration
OUTLINE
Men with biopsy-proven adenocarcinoma of the prostate scheduled to undergo radical prostatectomy at University of California San Francisco UCSF within 12 weeks of enrollment will receive infusion with hyperpolarized 13C bicarbonate and undergo metabolic MR imaging with endorectal coil Participants will be followed for 5-9 days after the hyperpolarized 13C-bicarbonate injection or removal from study or until death whichever occurs first Participants removed from study for unacceptable study related adverse events will be followed until resolution or stabilization as determined by the investigator or until initiation of new anti-cancer therapy whichever occurs first
I To determine the feasibility of tumor pH measurement in men with prostate cancer using hyperpolarized 13C bicarbonate imaging
SECONDARY OBJECTIVE
I To determine the safety of administration of hyperpolarized 13C-bicarbonate
EXPLORATORY OBJECTIVES
I To correlate the measurement of tissue pH with pathologic grade
II To correlate tissue pH maps with immunohistochemistry staining IHC gene expression RNA-Seq and spatial transcriptomics Bristol Myers Squibb BMS collaboration
OUTLINE
Men with biopsy-proven adenocarcinoma of the prostate scheduled to undergo radical prostatectomy at University of California San Francisco UCSF within 12 weeks of enrollment will receive infusion with hyperpolarized 13C bicarbonate and undergo metabolic MR imaging with endorectal coil Participants will be followed for 5-9 days after the hyperpolarized 13C-bicarbonate injection or removal from study or until death whichever occurs first Participants removed from study for unacceptable study related adverse events will be followed until resolution or stabilization as determined by the investigator or until initiation of new anti-cancer therapy whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-03218 | REGISTRY | NCI Clinical Trials Reporting Program CTRP | None |