Recruiting

PET/MR with Ga-PentixaFor

Sponsor:

University Health Network, Toronto

Code:

NCT06871176

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[68Ga]Ga-PentixaFor

Study Details

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

Study ID

NCT06871176

Start date

Apr 22, 2025

Status verified date

Jun, 2025

Completion date

Mar 4, 2028

Anticipated

Primary completion date

Mar 4, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria

  • 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

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
  • 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)

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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.

Interventions

[68Ga]Ga-PentixaFor

\[68Ga\]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.

Primary outcome measure

  • Diagnostic Accuracy of CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Compared to Standard of Care Imaging [ Time Frame: Baseline (at initial staging) ]

Central Contacts and Locations

Central contacts

Patrick Veit-Haibach, MD

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

Vishal Kukreti, MD

vishal.kukreti@uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 25, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-06-25.