Chemical-Shift-Encoded MRI for Prostate Cancer

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Overseen ByCancer Connect
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging method, chemical shift-encoded MRI, matches the accuracy of a PET scan using the tracer 3'-Deoxy-3'-[18F]-fluorothymidine in detecting active bone marrow in men with advanced prostate cancer. The study uses both imaging techniques on the same day to compare their effectiveness. Men diagnosed with prostate cancer and scheduled to receive the treatment 177Lu-PSMA may be suitable candidates for this trial. As an Early Phase 1 trial, this research seeks to understand how the new imaging method functions in people, offering participants a chance to contribute to groundbreaking advancements in prostate cancer diagnostics.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop taking any medications that impact bone marrow, such as those that stimulate or suppress it. If you're on chemotherapy or certain radiotherapy, you need to wait 4 weeks before participating.

What prior data suggests that these imaging procedures are safe?

Research has shown that chemical-shift-encoded MRI (CSE-MRI) safely captures detailed images of the body's interior, similar to a regular MRI. Reports of major side effects are absent, and patients generally tolerate it well.

Fluorothymidine F-18 PET (FLT PET) is also considered safe. It uses a tiny amount of a radioactive substance to highlight active areas in the body. Studies indicate that this method usually has minimal side effects, with any negative reactions being rare and mild.

Both CSE-MRI and FLT PET are non-invasive, meaning they don't involve surgery or entering the body, which generally makes them safer than more invasive procedures. If concerns about radiation or other aspects of these imaging methods arise, discussing them with the study team is advisable.12345

Why are researchers excited about this trial?

Researchers are excited about the Chemical-Shift-Encoded MRI technique because it offers a novel way to visualize and assess prostate cancer, potentially enhancing the accuracy of current imaging methods. Unlike traditional imaging techniques, such as standard MRI or CT scans, this method uses chemical-shift encoding to generate detailed maps of fat distribution, which could provide new insights into tumor characteristics and treatment responses. Additionally, the use of 3'-Deoxy-3'-[18F]-fluorothymidine (FLT) in PET scans helps in assessing the proliferation of bone marrow, giving a clearer picture of cancer activity. This dual approach could lead to more tailored treatment plans and better outcomes for patients with metastatic prostate cancer.

What evidence suggests that CSE-MRI is effective for distinguishing active from inactive marrow in metastatic prostate cancer?

Research has shown that a new type of MRI, called chemical-shift-encoded MRI (CSE-MRI), is gaining popularity for its potential to detect prostate cancer. Some studies suggest that advanced imaging methods like CSE-MRI can help doctors better identify prostate cancer and determine if it has spread, which is crucial for selecting the right treatment. However, evidence remains insufficient, and further research is needed to assess its accuracy compared to other methods. In this trial, participants will undergo CSE-MRI to generate a fat fraction map, potentially offering insights into cancer activity. The hope is that CSE-MRI could match or surpass current imaging techniques, providing a non-invasive way to monitor cancer activity in patients.678910

Who Is on the Research Team?

ML

Michael Lawless, PhD

Principal Investigator

UW School of Medicine and Public Health

Are You a Good Fit for This Trial?

This trial is for men with metastatic prostate cancer who are able to undergo MRI and PET scans. Participants must be willing to have both imaging tests done at the same time. People who can't safely have an MRI or PET scan, such as those with certain implants or allergies, cannot join.

Inclusion Criteria

Patients must be informed of the experimental nature of the study and its potential risks, and must sign IRB approved consent form indicating such understanding
I am at least 18 years old.
I am able to care for myself and perform daily activities.
See 4 more

Exclusion Criteria

Any side effects from my previous cancer treatments are mild or have gone away.
I do not have any uncontrolled illnesses or conditions that would prevent me from following study requirements.
I am currently taking medication that affects my bone marrow.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Treatment

Participants receive up to 6 doses of 177Lu-PSMA RPT every 6 weeks, with imaging assessments including FLT PET and CSE-MRI

36 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the final administration of 177Lu-PSMA RPT

6 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 3'-Deoxy-3'-[18F]-fluorothymidine
  • Chemical-shift-encoded MRI

Trial Overview

The study compares two imaging methods—FLT PET and chemical-shift-encoded MRI—to see if the newer MRI technique can accurately identify active bone marrow like FLT PET does. Both scans will be performed on each participant using a combined scanner.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants scheduled to receive 177Lu-PSMAExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

GE Healthcare

Industry Sponsor

Trials
307
Recruited
634,000+
Fotis Vlachos profile image

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini profile image

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

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This study looks at the safety of the study drug, darolutamide, in Korean patients with nmCRPC or mHSPC. Darolutamide is currently available for doctors to ...

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This is an open label, single arm, phase 1b study to determine the safety of combining sequential Prostate-Specific Membrane Antigen ...

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Our discussion today is going to focus on current standards in mCRPC [metastatic castration-resistant prostate cancer], and I'll focus discussion on the recent ...