RECRUITING

Diffusion Basis Spectrum Imaging of the Prostate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.

Official Title

Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer

Quick Facts

Study Start:2020-02-27

Study Completion:2027-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04420702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Over 18 years of age and willing and able to provide informed consent. * Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort") * Including those men with: * an elevated PSA and no prior biopsy * an elevated PSA and a negative prior biopsy * Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort")	* Patients with any clinical contraindication to MRI * Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators * Those with cochlear implants * Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate) * Those who cannot lie flat for over 1 hour * Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)

Inclusion Criteria

Exclusion Criteria

* Over 18 years of age and willing and able to provide informed consent.
* Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort")
* Including those men with:
* an elevated PSA and no prior biopsy
* an elevated PSA and a negative prior biopsy
* Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort")

* Patients with any clinical contraindication to MRI
* Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators
* Those with cochlear implants
* Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate)
* Those who cannot lie flat for over 1 hour
* Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)

Contacts and Locations

Study Contact

Joseph Ippolito, M.D.

CONTACT

314-362-2925

ippolitoj@wustl.edu

Alex Klim

CONTACT

314-747-9781

klima@wustl.edu

Principal Investigator

Joseph Ippolito, M.D.

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Joseph Ippolito, M.D., PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-27

Study Completion Date2027-05-31

Study Record Updates

Study Start Date2020-02-27

Study Completion Date2027-05-31

Terms related to this study

Keywords Provided by Researchers

Prostate Cancer

Additional Relevant MeSH Terms

Prostate Cancer