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An Investigational Scan (7 Tesla MRI) in Diagnosing Cognitive Impairment in Patients With Non-Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04318028
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Brief Summary:
This trial studies 7 Tesla magnetic resonance imaging (MRI) in diagnosing cognitive impairment in patients with prostate cancer that has not spread to other places in the body (non-metastatic) and who have or have not received androgen deprivation therapy (ADT). The MRI machine uses a strong magnet and radio wave to make images of the inside of the body. A stronger magnetic field allows greater signals and more detailed visualization of the structure and function of human body. Giving 7 Tesla MRI may help doctors learn if patients that receive ADT show more signs of cognitive dysfunction or brain fog compared to patients to patients that do not receive ADT.

Condition or disease Intervention/treatment Phase
Non-Metastatic Prostate Carcinoma Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage IIA Prostate Cancer AJCC v8 Stage IIB Prostate Cancer AJCC v8 Stage IIC Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Radiation: 7 Tesla Magnetic Resonance Imaging Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Observe longitudinal changes in structural connectivity using T1-weighted and diffusion tensor MRI in men with non-metastatic prostate cancer on current ADT versus those who were not.

II. Observe longitudinal changes in brain functional connectivity using resting-state functional (rsf) MRI.

III. Observe longitudinal changes in brain metabolic profiles evaluated by MR spectroscopy (MRS).

IV. Exploratory assessment of correlation between testosterone and prostate specific antigen (PSA) levels with MRI measures and cognitive measures.

SECONDARY OBJECTIVES:

I. To assess the feasibility and acceptability of this approach using sequential 7T MRI in prostate cancer patients either receiving ADT or not.

OUTLINE:

Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and at 6-9 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Study of 7 Tesla MRI Neuroimaging Biomarkers of Prostate Cancer-Related Cognitive Impairment
Actual Study Start Date : August 11, 2020
Estimated Primary Completion Date : August 11, 2022
Estimated Study Completion Date : August 11, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (7 Tesla MRI)
Patients undergo 7 Tesla MRI over 30-90 minutes at baseline and 6-9 months.
Radiation: 7 Tesla Magnetic Resonance Imaging
Undergo 7 Tesla MRI
Other Names:
  • 7 Tesla MRI
  • 7T MRI




Primary Outcome Measures :
  1. Brain structural connectivity [ Time Frame: Up to 1 year ]
    Will be measured using T1-weighted and diffusion tensor magnetic resonance imaging (MRI).

  2. Brain functional connectivity [ Time Frame: Up to 1 year ]
    Will be measured using resting-state functional MRI.

  3. Brain metabolic profiles [ Time Frame: Up to 1 year ]
    Will be evaluated by MR spectroscopy.


Other Outcome Measures:
  1. Assessment of testosterone and prostate specific antigen (PSA) levels [ Time Frame: Up to 1 year ]
    For the correlation of between testosterone and PSA levels with MRI measures and cognitive measures, the study will use scatter plots to explore the pattern of correlation. Spearmen's correlation will be used to test the correlation. Both groups will be combined for the correlation analysis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent
  • Group 1 (G1): Non-metastatic biopsy-proven prostate cancer patients on current ADT and
  • Group 2 (G2): Demographically (age, cancer stage) matched non-metastatic biopsy proven prostate cancer patients without a history of ADT
  • Ability to undergo imaging procedure without any form of sedation
  • Ability to complete brief cognitive testing on iPad

Exclusion Criteria:

  • History of dementia or other neuropsychiatric disease
  • History of other cancer medical therapies other than ADT, narcotics or psychiatric medications
  • Standard contraindications for MRI:

    • Prior work as a machinist or metal worker, or history of metal being removed from the eyes,
    • Cardiac pacemaker or internal pacing wires,
    • Non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or
    • Claustrophobia, or uncontrollable motion disorder
  • Currently active second malignancy
  • Any significant cardiovascular conditions (New York Heart Association [NYHA]) class III or IV congestive heart failure, myocardial infarction within 6 months, unstable angina, pacemaker); or
  • Renal disease with calculated creatinine clearance of < 45 ml/min

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318028


Contacts
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Contact: Bhushan Desai 323-442-7469 Bhushan.Desai@med.usc.edu

Locations
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United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Mark S. Shiroishi    323-226-7425    Mark.Shiroishi@med.usc.edu   
Principal Investigator: Mark S. Shiroishi         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mark S Shiroishi, MD University of Southern California
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT04318028    
Other Study ID Numbers: 4P-19-4
NCI-2019-05018 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4P-19-4 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Cognitive Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders