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Chemical-Shift-Encoded MRI for Active Bone Marrow Dosimetry in Radiopharmaceutical Therapy

ConditionMetastatic Castration-resistant Prostate Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

This study compares two different imaging procedures to each other, one using positron emission tomography (PET) with fluorothymidine F-18 (FLT) (FLT PET for short), and the other using chemical shift-encoded (CSE) magnetic resonance imaging (MRI) or CSE-MRI for short, to determine specifically if CSE-MRI is as accurate as FLT PET in telling the difference between active and inactive marrow. The best way to do the comparison between the two imaging procedures is if they are done at the same time on the same patient. This is possible with use of a scanner at the University of Wisconsin Hospitals and Clinics (UW Health), the GE SIGNA PET/MR scanner. The prediction is that CSE-MRI as accurate as FLT at telling the difference between active and inactive marrow in patients with metastatic prostate cancer, and that is the primary reason for this study. 15 participants will be enrolled and on study for up to 14 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Patients must be informed of the experimental nature of the study and its potential risks, and must sign institutional review board (IRB) approved consent form indicating such understanding.

Individuals at least 18 years of age.

Patients must have histologically or cytologically confirmed prostate cancer.

Disqualifiers

Patients receiving any concurrent therapy known to impact bone marrow (either stimulate or suppress the marrow, for example G-CSF).

Patients treated with chemotherapy or 223Ra radiotherapy within 4 weeks.

All acute toxic effects of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to a grade ≤ 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (CTCAE).

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements per treating physician discretion.

Trial design

Design model

Single group

Treatments tested in this trial

  • 3'-Deoxy-3'-[18F]-fluorothymidine

    Drug

    Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. This is expected to last 2-3 hours. FLT injections will be administered one hour before imaging for tracer uptake. Participants will receive an IV injection of up to 10 mCi (370 MBq) of 18F-FLT. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy.

  • Chemical-shift-encoded MRI

    Device

    Within 29 days prior to 177Lu-PSMA RPT, participants will undergo 18F-FLT PET to assess proliferating bone marrow and CSE-MRI to generate a fat fraction map on a GE SIGNA PET/MR scanner. This is expected to last 2-3 hours. The patient will receive 1 CSE-MRI/FLT PET scan prior to the start of therapy. Up to 3 CSE-MRI scans will be completed as part of this study. At the physician's discretion, a single standard of care (SOC) mid-treatment PSMA PET/MRI can be performed any time during cycles 2-4, and a SOC post-treatment can be done within 6 months of final treatment. CSE-MRI will be acquired during these scans.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Participants scheduled to receive 177Lu-PSMAExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Mean Dice similarity coefficient (DSC)

The mean Dice similarity coefficient (DSC) between active bone marrow volumes derived from CSE-MRI and ¹⁸F-FLT PET across all enrolled patients. A mean DSC of ≥0.7 will indicate that CSE-MRI is a clinically acceptable alternative to FLT PET for identifying ABM

Time frame
up to 14 months

Secondary outcomes

1

Difference in Mean Tumor Absorbed Dose (Gy)

Difference in mean tumor absorbed dose (Gy) across three lesion-segmentation methods, with segmentation performance characterized by DSC relative to physician manual contours.

Time frame
up to 14 months
2

Variance in Tumor and Bone Marrow Volume

Repeatability will be measured by variance in tumor and bone marrow volumes.

Time frame
up to 14 months
3

Variance in Tumor and Bone Marrow Doses

Repeatability will be measured by variance in tumor and bone marrow doses

Time frame
up to 14 months
4

Difference in Mean Absorbed Dose (Gy)

Difference in mean absorbed dose (Gy) between conventional and CSE-MRI-based ABM dosimetry methods

Time frame
up to 14 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

GE Healthcare

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: