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

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, which combines PET and MR scans with a special tracer ([68Ga]Ga-PentixaFor), can better diagnose Multiple Myeloma, a cancer that mainly affects bones. Researchers hope this new scan will be more precise than current imaging tests. The trial seeks individuals diagnosed with Multiple Myeloma, specifically those who haven't received treatment beyond the first course. Eligible participants must be able to lie still for certain imaging tests. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve diagnostic methods for future patients.

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 prior data suggests that this PET/MR scan is safe for diagnosing Multiple Myeloma?

Research has shown that [68Ga]Ga-PentixaFor, a new substance used in PET/MR scans, may help doctors more easily detect certain cancers, such as lymphoma and possibly multiple myeloma. In earlier studies, this substance created clearer images of cancer in the body, allowing doctors to more accurately assess how the disease affects bones and other organs.

Regarding safety, patients have generally tolerated [68Ga]Ga-PentixaFor well in scans. Studies using similar scanning methods have reported no major serious side effects. Improvements in the production of this substance have ensured it meets medical standards, suggesting it is safe for use in scans.

In summary, while ongoing research continues, [68Ga]Ga-PentixaFor has so far been safe for use in imaging tests, with no significant safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the investigational imaging technique using [68Ga]Ga-PentixaFor for multiple myeloma because it represents a potentially groundbreaking advancement in diagnostic imaging. Unlike standard imaging methods, such as MRI or CT scans, this technique specifically targets the CXCR4 receptor, which is often overexpressed in multiple myeloma cells. This targeted approach could lead to more precise detection and characterization of the disease, offering valuable insights for diagnosis, prognosis, and therapy planning. By honing in on the CXCR4 receptor, researchers anticipate that [68Ga]Ga-PentixaFor PET/MR imaging might provide clearer, more informative images, potentially leading to earlier and more accurate treatment decisions.

What evidence suggests that this PET/MR scan is effective for diagnosing Multiple Myeloma?

Research has shown that a new imaging method using [68Ga]Ga-PentixaFor holds promise for diagnosing multiple myeloma, a type of blood cancer. In this trial, participants will undergo the investigational imaging modality, CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR, to assess its diagnostic, prognostic, and therapeutic value. Studies suggest this method can better predict disease progression in newly diagnosed patients. [68Ga]Ga-PentixaFor targets a protein called CXCR4, found in large amounts in multiple myeloma cells, which helps the imaging method clearly highlight affected areas. As a result, doctors might more accurately determine disease spread compared to standard imaging methods. Early findings indicate that this new technique could enhance how doctors determine the disease stage and monitor its progress. ^{1 4 6 7 8}

Who Is on the Research Team?

Patrick Veit-Haibach, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06871176

NCT06871176 | PET/MR Scan With [68Ga]Ga-PentixaFor ...

The investigators will compare the performance of [68Ga]Ga-PentixaFor PET/MR to standard imaging methods (18F-FDG-PET/CT and MRI) to see if CXCR4-targeted ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38286937/

[ 68 Ga]Pentixafor PET/CT for staging and prognostic ...

[ 68 Ga]Pentixafor PET/CT-based staging possesses substantial potential to predict disease progression in newly diagnosed MM patients.

3.

trialx.com

trialx.com/clinical-trials/listings/299478/petmr-scan-with-68gaga-pentixafor-cxcr4-vs-standard-of-care-soc-for-initial-staging-and-follow-up-in-multiple-myeloma-mm/

PET/MR Scan With [68Ga]Ga-PentixaFor (CXCR4) vs ...

This study aims to improve the accuracy of diagnosing and monitoring Multiple Myeloma using more advanced imaging techniques. Description.

4.

thno.org

thno.org/v07p0205.htm

[ 68 Ga]Pentixafor-PET/CT for imaging of chemokine ...

This study assessed the diagnostic performance of the CXCR4-directed radiotracer [ 68 Ga]Pentixafor in MM and a potential role for stratifying patients to CXCR ...

5.

researchgate.net

researchgate.net/publication/377807490_GaPentixafor_PETCT_for_staging_and_prognostic_assessment_of_newly_diagnosed_multiple_myeloma_comparison_to_FFDG_PETCT?_fam=1

[Ga]Pentixafor PET/CT for staging and prognostic ...

Purpose To evaluate the prognostic performance of [⁶⁸Ga]Pentixafor PET/CT at baseline for staging of patients with newly diagnosed multiple ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9367619/

The Role of [68Ga]Ga-Pentixafor PET/CT or PET/MRI in ...

Preliminary evidence about the useful impact of [68Ga]Ga-Pentixafor PET/CT or PET/MRI in lymphoma is available but reveals heterogeneous findings.

7.

nature.com

nature.com/articles/s41598-024-84096-7

On the automated radiosynthesis of pharmaceutical grade ...

In the present study, we have optimized a cGMP-compliant automated radiosynthetic method for obtaining clinical grade [68Ga]Ga-Pentixafor, using ...

8.

jnm.snmjournals.org

jnm.snmjournals.org/content/56/3/410

Biodistribution and Radiation Dosimetry for the ...

The aim of this article was to quantify the biokinetics and the dosimetry of 68Ga-pentixafor in multiple-myeloma patients. MATERIALS AND ...