PET/MR Scan for Multiple Myeloma

Overseen By Patrick Veit-Haibach, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Pregnancy, Inability to consent, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Multiple myeloma is a disease mainly located in participants bones. Usually a participants physician arrives at this diagnosis by doing blood tests and ordering standard of care imaging tests (18F-FDG PET/CT and maybe additional MRI) to see how many bones (and/or other organs) are affected. While these two imaging tests are already very good, recent research indicates that even more precise imaging methods could be used to diagnose participants disease more precisely. The purpose of this study is to learn if a combined PET/MR scan with a new radiotracer, \[68Ga\]Ga-PentixaFor, can provide more accurate and precise diagnostic information in patients with Multiple Myeloma, a type of cancer primarily affecting the bones. This study aims to improve the accuracy of diagnosing and monitoring Multiple Myeloma using more advanced imaging techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment [68Ga]Ga-PentixaFor for multiple myeloma?

Research shows that [68Ga]Ga-PentixaFor PET/CT can effectively detect multiple myeloma by targeting a specific protein (CXCR4) that is often found in high amounts in this disease. However, it may not be as effective in detecting certain types of recurrent multiple myeloma, especially when the disease spreads outside the bone marrow. ^{1 2 3 4 5}

Is 68Ga-Pentixafor PET/CT safe for humans?

The research articles do not provide specific safety data for 68Ga-Pentixafor PET/CT, but they focus on its use in imaging for multiple myeloma. Generally, PET/CT scans are considered safe, but it's important to discuss any concerns with your doctor. ^{1 2 3 4 5}

How is the drug [68Ga]Ga-PentixaFor unique in treating multiple myeloma?

The drug [68Ga]Ga-PentixaFor is unique because it uses a radioactive tracer for PET/MR imaging, which helps in visualizing and diagnosing multiple myeloma by highlighting areas of increased blood vessel formation in tumors, a method not typically used in standard treatments for this condition. ^{6 7 8 9 10}

Research Team

Patrick Veit-Haibach, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for individuals diagnosed with Multiple Myeloma, a cancer affecting the bones. It's designed to see if a new PET/MR scan using [68Ga]Ga-PentixaFor can give more precise diagnostic information than current standard imaging tests.

Inclusion Criteria

I am older than 18 years.

I have a specific type of multiple myeloma and haven't received treatment beyond the first course.

Exclusion Criteria

Any contra-indications for MRI or 18F-FDG PET/CT imaging according to institutional guideline

Pregnancy (will be ruled out as per institutional protocol)

Inability to lie still in prone position in MRI for at least 30 min or PET/CT for at least 30 min

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Staging

Participants undergo initial staging with CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR imaging compared to standard imaging methods

Baseline

Treatment Decision Making

Evaluation of how CXCR4 PET/MR imaging influences treatment decisions, including preconditioning and stem cell transplantation considerations

Post-initial staging

Response Assessment

Assessment of therapy response using CXCR4 PET/MR imaging to guide follow-up and supportive therapy decisions

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events related to radiopharmaceutical administration

6 months

Treatment Details

Interventions

• [68Ga]Ga-PentixaFor

Trial Overview [68Ga]Ga-PentixaFor is being tested as a radiotracer in PET/MR scans for its potential to improve the accuracy of diagnosing and monitoring Multiple Myeloma compared to standard imaging methods like 18F-FDG PET/CT and MRI.

Participant Groups

Group I: CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Experimental Treatment 1 Intervention

This arm involves patients undergoing the investigational imaging modality, CXCR4-targeted \[68Ga\]Ga-PentixaFor PET/MR, to evaluate its diagnostic, prognostic, and therapeutic value in comparison to standard imaging methods.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

68Ga-PSMA PET/MRI has demonstrated high diagnostic accuracy for staging primary prostate cancer, showing equivalent effectiveness to 68Ga-PSMA PET/CT in detecting critical features like extracapsular extension, seminal vesicle invasion, and lymph node metastasis.

The analysis included 27 studies, indicating that while both imaging modalities are effective, further direct comparisons are necessary to fully establish the advantages of 68Ga-PSMA PET/MRI over PET/CT in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 68Ga-labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Magnetic Resonance Imaging and Positron Emission Tomography/Computed Tomography for Primary Staging of Prostate Cancer: A Systematic Review and Meta-analysis. Ling, SW., de Jong, AC., Schoots, IG., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Multiple Myeloma Presenting as a Superscan on 68Ga-Pentixafor PET/CT. [2018]

2. Japan pubmed.ncbi.nlm.nih.gov

Prognostic significance of 68Ga-Pentixafor PET/CT in multiple myeloma recurrence: a comparison to 18F-FDG PET/CT and laboratory results. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

68Ga-Pentixafor PET/CT May Fail to Detect Recurrent Multiple Myeloma with Extramedullary Disease. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Imaging CXCR4 receptors expression for staging multiple myeloma by using 68Ga-Pentixafor PET/CT: comparison with 18F-FDG PET/CT. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

68Ga-PSMA PET/CT Imaging in Multiple Myeloma. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

Comparison of hybrid (68)Ga-PSMA PET/MRI and (68)Ga-PSMA PET/CT in the evaluation of lymph node and bone metastases of prostate cancer. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Gallium 68 PSMA-11 PET/MR Imaging in Patients with Intermediate- or High-Risk Prostate Cancer. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Discrepancy between Multiparametric Magnetic Resonance Imaging and 68Ga Prostate-Specific Membrane Antigen Positron Emission Tomography: A Simultaneous Acquired Positron Emission Tomography-Magnetic Resonance Imaging Case. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Comparison of 68Ga-labeled Prostate-specific Membrane Antigen Ligand Positron Emission Tomography/Magnetic Resonance Imaging and Positron Emission Tomography/Computed Tomography for Primary Staging of Prostate Cancer: A Systematic Review and Meta-analysis. [2022]