Clinical trial · Interventional

PCMRI - an MRI/TRUS System for the Evaluation of the Prostate

NCT00542100CI-TRIAL-00000913PCMRIunknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

The aim of the clinical study is to evaluate the convenience and efficacy of the PCMRI in the assessment of the prostate in humans. The study cohort will include 50 patients and is designed to be non-comparative to other diagnostic methods.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
PCMRI	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
1
interventionNames
1. Device: PCMRI
type
EXPERIMENTAL
label
2
interventionNames
1. Device: PCMRI

Primary outcomes (2)

measure
Efficacy of the PCMRI system in PC detection
timeFrame
one year
measure
Safety of the PCMRI system in PC detection
timeFrame
one year

Secondary outcomes (4)

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 25 Years
Maximum age: 80 Years

Show eligibility criteria text

Inclusion criteria for trial group:

* Age between 45 and 80 years old.
* Presumably Stage 2 and higher prostate carcinoma as determined by the PI.
* At least 6 weeks after the last biopsy session.
* Prior to any PC treatment. for control group:
* Age between 25 and 35 years old.
* No family history of PC.
* No lower urinary tract symptoms. Exclusion criteria for both groups:
* History of hemorrhoids.
* History of prostetitis

References

Publications (0)

Data not yet available

No reference posted for this study.