7 Tesla MRI Scan for Cognitive Impairment in Prostate Cancer

Overseen By Bhushan Desai

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Southern California

Must be taking: Androgen deprivation

Must not be taking: Narcotics, Psychiatric medications

Disqualifiers: Dementia, Neuropsychiatric disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a high-tech MRI scan can help doctors detect brain fog in men with non-metastatic prostate cancer. It examines patients receiving hormone therapy (androgen deprivation therapy, or ADT) and those who are not, to determine if the therapy affects brain function. The trial uses detailed brain images from a powerful MRI (7 Tesla Magnetic Resonance Imaging). Men with non-metastatic prostate cancer, whether on ADT or not, who can undergo an MRI without sedation, may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance understanding of brain health in prostate cancer patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on narcotics or psychiatric medications, you may not be eligible to participate.

What prior data suggests that this MRI technique is safe for diagnosing cognitive impairment?

Research has shown that 7 Tesla MRI scans are generally safe for patients. Studies have found that 7 Tesla MRI provides clearer images than standard MRI machines, aiding doctors in detecting small changes in the brain more easily. Importantly, no major safety concerns have been reported with the use of 7 Tesla MRI.

This study focuses on diagnostics, not treatment, and the MRI is non-invasive, meaning it doesn't physically enter the body. Most people tolerate it well. Some might feel uncomfortable in the small space of the MRI machine, but this is common for all MRI tests. If metal implants or devices are present, it is important to inform the medical team before the scan. Overall, evidence suggests that 7 Tesla MRI is a safe method for examining brain function in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the 7 Tesla MRI for cognitive impairment in prostate cancer patients because it offers a super high-resolution view of the brain, unlike standard imaging techniques. While traditional MRI machines use a 1.5 or 3 Tesla magnet, the 7 Tesla MRI provides much more detailed images, potentially uncovering subtle brain changes related to cognitive issues. This could lead to earlier detection and better understanding of cognitive impairment, paving the way for more effective interventions.

What evidence suggests that 7 Tesla MRI is effective for diagnosing cognitive impairment in prostate cancer?

Research has shown that 7 Tesla MRI scans provide very detailed images of the body's internal structures due to their stronger magnetic field compared to standard MRI machines. Studies have found that these scans accurately assess tiny structures, such as nerve roots, which can be crucial for diagnosing conditions. In this trial, participants will undergo 7 Tesla MRI to identify cognitive changes in prostate cancer patients. The advanced imaging may help doctors detect early signs of cognitive impairment. This could be particularly beneficial for patients receiving androgen deprivation therapy (ADT), as it might reveal brain changes related to the treatment. ^{2 4 6 7 8}

Who Is on the Research Team?

Mark S Shiroishi, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for men with non-metastatic prostate cancer, divided into two groups: those currently on androgen deprivation therapy (ADT) and those who've never had ADT. Participants must be able to consent, complete cognitive tests on an iPad, and have no severe kidney issues or incompatible medical devices like pacemakers. They shouldn't have heart failure, recent heart attacks, other active cancers, a history of metal work in the eyes or dementia.

Inclusion Criteria

I have prostate cancer that has not spread and I've never had hormone therapy.

I have prostate cancer that has not spread and am currently on hormone therapy.

Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria

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

I have only used ADT, narcotics, or psychiatric meds for my cancer.

History of dementia or other neuropsychiatric disease

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo 7 Tesla MRI over 30-90 minutes to assess baseline brain structural and functional connectivity, and metabolic profiles

1 day

1 visit (in-person)

Follow-up Assessment

Participants undergo 7 Tesla MRI over 30-90 minutes at 6-9 months to observe longitudinal changes in brain connectivity and metabolic profiles

6-9 months

1 visit (in-person)

Follow-up

Participants are monitored for changes in cognitive measures and correlation with testosterone and PSA levels

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• 7 Tesla Magnetic Resonance Imaging

Trial Overview The study is testing if a high-powered MRI scan called 7 Tesla can detect cognitive changes in patients with prostate cancer. It compares brain images from patients receiving ADT to those not on this treatment to see if there's more 'brain fog' or cognitive dysfunction associated with ADT.

How Is the Trial Designed?

Group I: Diagnostic (7 Tesla MRI) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2019-05018

An Investigational Scan (7 Tesla MRI) in Diagnosing ... This trial studies 7 Tesla magnetic resonance imaging (MRI) in diagnosing cognitive impairment in patients with prostate cancer that has not spread to other ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8505159/

7 Tesla and Beyond - PubMed Central - NIH Three-dimensional dual-echo steady-state MRI at 7 T has been shown to allow precise assessment of the microanatomy of intraspinal cervical nerve roots.

3. withpower.com withpower.com/trial/phase-prostatic-neoplasms-7-2020-b1440

7 Tesla MRI Scan for Cognitive Impairment in Prostate ... This trial studies 7 Tesla magnetic resonance imaging (MRI) in diagnosing cognitive impairment in patients with prostate cancer that has not spread to other ...

4. nature.com nature.com/articles/s41391-024-00827-x

Prostate cancer detection and complications of MRI ... Prostate cancer detection and complications of MRI-targeted prostate biopsy using cognitive registration, software-assisted image fusion or in- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2211568417301687

Evaluation of MR imaging-targeted biopsies of the prostate ... The aim of this study was to evaluate the differences in prostate cancer detection rate and biopsy effectiveness between an MRI-TB and a transperineal 12-core ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11846079/

Clinical 7 Tesla magnetic resonance imaging - PubMed Central Seven Tesla MRI provides significantly superior detection of microbleeds compared to 3 T, increasing the detected prevalence in AD and mild ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12106061/

Prostate cancer detection and complications of MRI-targeted ... This unique study, exclusively focusing on comparative research, indicates no significant differences in csPCa and iPCa detection rates between COG-TB, FUS-TB, ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa2209454

Prostate Cancer Screening with PSA and MRI Followed by ... Prostate cancer screening with magnetic resonance imaging: results from the second round of the Göteborg Prostate Cancer Screening 2 trial.