Clinical trial · Interventional
Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer
Repeatability Assessment of Quantitative DCE-MRI and DWI: A Multicenter Study of Functional Imaging Standardization in the Prostate
NCT01562223CI-TRIAL-00054502A6701QIBAunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Diagnostic procedures, such as dynamic contrast-enhanced magnetic resonance imaging or DCE-MRI and diffusion-weighted imaging or DWI, may provide images of prostate cancer or any cancer that remains after biopsy. PURPOSE: This trial studies repeated DCE-MRI and DWI in patients diagnosed with prostate cancer.
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 |
|---|---|---|---|
| motexafin gadolinium | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Repeatability Assessment
- description
- Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability.
- interventionNames
- Other: motexafin gadolinium
Primary outcomes (1)
- measure
- Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)
- timeFrame
- 2 to 14 Days
- description
- The repeatability coefficient (RC) and its 95% confidence interval (CI) will be estimated for each metric \[ ktrans, IAUGC90bn\] using the method of Barnhart and Barboriak, 2009
Secondary outcomes (2)
- measure
- Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of prostate adenocarcinoma by transrectal ultrasound (TRUS)-guided biopsy between 28 to 90 days prior to enrollment * Minimal tumor burden as defined by at least one of the following criteria: * One single core with ≥ 50% cancer burden and ≥ 5 mm tumor length * Two or more cores in the same prostate region, each with ≥ 30% cancer burden * Three or more cores positive for prostate cancer (of any magnitude of cancer burden) in the same prostate region * Gleason score of 7 or higher cancer burden * Prostate-specific antigen (PSA) ≥ 10 ng/mL PATIENT CHARACTERISTICS: * Able to tolerate magnetic resonance imaging (MRI) required by protocol, to be performed at an American College of Radiology Imaging Network (ACRIN)-qualified facility and scanner * Not suitable to undergo MRI or gadolinium-based contrast agent because of: * Severe claustrophobia not relieved by oral anxiolytics per institutional standard practice * Presence of MRI-incompatible metallic objects or implanted medical devices in body (including, but not limited to, non-MRI compatible metal objects, cardiac pacemaker, aneurysm clips, artificial heart valves with steel parts, or metal fragments in the eye or central nervous system) * Renal failure, as determined by glomerular filtration rate (GFR) \< 30 mL/min based on a serum creatinine level obtained within 48 hours prior to enrollment * Weight greater than that allowable by the MRI table, per local institutional practice PRIOR CONCURRENT THERAPY: * No anti-androgenic therapy within 30 days prior to enrollment * No prior external-beam radiotherapy, proton radiotherapy, or brachytherapy to the prostate * No prior hip replacement or other major pelvic surgery
References
Publications (0)
Data not yet available
No reference posted for this study.