Clinical trial · Interventional
3T Perfluorocarbon-Filled Endorectal Magnetic Resonance Spectroscopic Imaging of Prostate
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objectives: The objectives of this study are to: 1) evaluate the feasibility of 3T MRSI of prostate in improving the spectral resolution, using a PFC-filled endorectal coil, 2) develop a systematic metabolic grading system for tumor detection by identifying the abnormal peak areas of Cho, Cr, Po, and Ci for the prostate carcinoma, specifically from PFC-filled endorectal 3T MRSI, and 3) evaluate the efficacy of the metabolic grading system in tumor detection. The long-term goal of the study is to provide an early prognostic indicator and means of monitoring the biologic status of the prostate cancer during the course of the disease.
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 |
|---|---|---|---|
| 3T Magnetic Resonance Spectroscopic Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3T MRSI Prostate
- description
- 3T Magnetic Resonance Spectroscopic Imaging
- interventionNames
- Procedure: 3T Magnetic Resonance Spectroscopic Imaging
Primary outcomes (1)
- measure
- Comparison of linewidths collected from AIR MRSI and PFC-MSRI
- timeFrame
- 2 MRSI studies should take about 60 minutes; study participation completed with prostatectomy to take place within 3 months of MRSI exams
- description
- The outcome variable for comparing linewidths between the two modalities is paired differences of measurements taken from the same patients. A paired t-test is used to test for a 50% decrease in the mean linewidth as measured by PFC-MRSI versus AIR-MRSI.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Biopsy proven, clinical stage 1-3 prostate carcinomas 2. Prostatectomy at M. D. Anderson within 3 months from the time of MRSI 3. An interval of \> 6 weeks between the biopsy and MRSI 4. Signed informed consent form Exclusion Criteria: 1. Contraindications for MRI (e.g. cardiac pacemaker) 2. Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum) 3. Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field 4. Previous prostate surgery for prostate carcinoma (including, 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
References
Publications (0)
Data not yet available