PET/MR Scan With [68Ga]Ga-PentixaFor (CXCR4) vs Standard of Care (SOC) for Initial Staging and Follow up in Multiple Myeloma (MM)

NCT06871176 | Recruiting

• 1 other identifier: 23-5828
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Compared to Standard of Care Imaging

  This primary outcome will assess the diagnostic accuracy of the CXCR4-targeted \[68Ga\]Ga-PentixaFor PET/MR imaging in comparison to the standard 18F-FDG PET/CT and MRI imaging in newly diagnosed multiple myeloma (MM) patients. Specifically, the focus will be on the number of bone marrow myeloma manifestations detected by CXCR4 PET/MR compared to standard imaging, as well as the number of extra-osseous myeloma manifestations detected.

  Baseline (at initial staging)

Secondary Outcomes (4)

• Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire

  Post-initial staging (before starting treatment)

• Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire

  3 months after start of participants therapy for MM

• Gather data to inform on patient selection for theranostics studies

  Baseline (initial staging)

• Monitoring for Adverse Events Related to Radiopharmaceutical Administration

  6 months (from baseline to final follow-up)

Study Arms (1)

CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging

EXPERIMENTAL

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.

Drug: [68Ga]Ga-PentixaFor

Interventions

[68Ga]Ga-PentixaFor DRUG

\[68Ga\]Ga-PentixaFor will be administered intravenously using the recommended activity for adults which is up to 150 MBq (4 mCi) fixed dose. There is no weight adaption recommended in the literature.

Also known as: CXCR4

CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 18 years of age
• Clinical diagnosis of (nonsecretory, oligosecretory, suspicion for extramedullary MM) MM. MM diagnosis is based on IMWG (International Myeloma Working Group) criteria.No treatment received beyond first course of

You may not qualify if:

• 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
• Patients or unwilling to use contraception during study and breastfeeding women can also not partake in this study
• Inability to provide consent
• Any hypersensitivity or known allergy to any component of the investigational product (\[68Ga\]Ga-PentixaFor)No concomitant other malignant hemato-oncological disease being diagnosed (i.e. additional lymphoma or leukemia)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Patrick Veit-Haibach, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Veit-Haibach, MD

CONTACT

416-340-4800 Ext. 6085; Patrick.Veit-Haibach@uhn.ca

Vishal Kukreti, MD

CONTACT

vishal.kukreti@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-arm, controlled, comparative study. Participants with newly diagnosed multiple myeloma will undergo both standard imaging (18F-FDG-PET/CT and MRI) and the investigational \[68Ga\]Ga-PentixaFor (CXCR4) PET/MR imaging. The study will assess the diagnostic accuracy and potential therapeutic influence of the CXCR4 PET/MR scan in comparison to the standard of care. The study will include both initial staging and follow-up imaging assessments, with an emphasis on how the new imaging modality influences treatment decisions.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 11, 2025
• Study Start: April 22, 2025
• Primary Completion (Estimated): March 4, 2028
• Study Completion (Estimated): March 4, 2028
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

CA (1)