Studying Repeated DCE-MRI and DWI in Patients Diagnosed With Prostate Cancer

NCT01562223 | Unknown DMC

• 4 other identifiers: CDR0000728901ACRIN-6701U01CA080098U01CA079778
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

stage IIA prostate cancer; stage IIB prostate cancer; stage III prostate cancer; stage IV prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)

  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

  2 to 14 Days

Secondary Outcomes (2)

• Test-retest performance, assessed by the RC of Ktrans, IAUGC90bn, and D(t), and measured by median pixel values of the prostate tumor

  2 to 14 Days

• Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans

  2 to 14 Days

Study Arms (1)

Repeatability Assessment

EXPERIMENTAL

Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability.

Other: motexafin gadolinium

Interventions

motexafin gadolinium OTHER

Also known as: Gadolinium

Repeatability Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Links

• National Cancer Institute's clinical trials database

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

motexafin gadolinium; Gadolinium

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Officials

• Mark A. Rosen

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: March 23, 2012
• Study Start: August 27, 2012
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 18, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)