NCT00429338

Brief Summary

The objective of this study is to evaluate the feasibility of 3T magnetic resonance spectroscopic imaging (MRSI) of the prostate in improving the spectral resolution, using a perfluorocarbon compound (PFC)-filled endorectal coil. Specific Aim 1: To compare the spectral quality, measured in Hz (linewidth), of 3T MRSI performed with an air-filled endorectal coil (AIR-MRSI) and a PFC-filled endorectal coil (PFC-MRSI). Specific Aim 2: To compare the quality of spectra of PFC-MRSI by grading the overall quality of MRSI data of each patient subjectively as being "excellent," "good," "fair," "poor," and "non-diagnostic," based on the status of subjective spectral resolution of Cho, Cr and Po peaks, signal to noise ratio (SNR), baseline distortion, and fat contamination.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

6.8 years

First QC Date

January 29, 2007

Last Update Submit

January 7, 2015

Conditions

Prostate Cancer

Keywords

GenitourinaryProstate CancerMagnetic Resonance ImagingMRIMagnetic Resonance Spectroscopic ImagingMRSIEndorectal MRSIEndorectal magnetic resonance spectroscopy imaging3 Tesla3T ScanEndorectal coilPerfluorocarbon compoundPFCPFC-filled endorectal coilPFC-MRSIAIR-MRSI

Outcome Measures

Primary Outcomes (1)

  • Spectral quality (linewidth) of 3T MRSI performed with air-filled endorectal coil (AIR-MRSI) and a PFC-filled endorectal coil (PFC-MRSI)

    Comparison of each linewidths (measured in Hz) between two modalities: endorectal magnetic resonance spectroscopy imaging (MRSI) of prostate using "3 Tesla (3T)" scanner with 1) perfluorocarbon compound (PFC) within endorectal coil versus 2) air.

    60 Minutes for 2 sets of MRIs

Secondary Outcomes (1)

  • Total number of patients for each grade from each group with AIR-MRSI and PFC-MRSI

    Patients: 60 Minutes for 2 sets of MRIs; Study Duration 4 Years

Study Arms (2)

AIR-MRSI

EXPERIMENTAL

Endorectal MRSI with Air

Procedure: AIR-MRSI

PFC-MRSI

EXPERIMENTAL

Endorectal MRSI with PFC

Procedure: PFC-MRSI

Interventions

AIR-MRSIPROCEDURE

3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with an air-filled endorectal coil (AIR-MRSI).

Also known as: Endorectal magnetic resonance spectroscopy imaging, Magnetic resonance imaging, MRI
AIR-MRSI
PFC-MRSIPROCEDURE

3T Magnetic Resonance Spectroscopic Imaging (MSRI) scan performed with a perfluorocarbon compound (PFC)-filled endorectal coil (PFC-MRSI).

Also known as: Endorectal magnetic resonance spectroscopy imaging, Magnetic resonance imaging, MRI
PFC-MRSI

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed biopsy proven prostate carcinoma who are referred to Diagnostic Imaging for magnetic resonance imaging (MRI) / magnetic resonance spectroscopic imaging (MRSI)
  • No previous radiation to prostate or pelvis
  • No hormonal treatment for prostate
  • The interval between the biopsy and magnetic resonance spectroscopic imaging (MRSI): more than 6 weeks
  • Informed consent

You may not qualify if:

  • Contraindications for MRI (e.g. cardiac pacemaker)
  • Allergy to Latex
  • Contraindications for magnetic resonance spectroscopic imaging (MRSI) (e.g. history of abdomino-perineal resection of rectum)
  • Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field
  • Previous prostate surgery for prostate carcinoma (including, transurethral resection of the prostate (TURP) and cryosurgery), local or systemic treatment for prostate carcinoma (e.g. radiation, androgen deprivation), pelvic radiation (e.g. rectal cancer), rectal surgery, BCG for bladder cancer
  • Children (\<18 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Haesun Choi, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 31, 2007

Study Start

January 1, 2007

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations

US(1)