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PET/MR-scanning med [68GA] GA-Pentixafor (CXCR4) vs Standard of Care (SOC) til indledende iscenesættelse og opfølgning i multiple myeloma (MM)

30. september 2026 opdateret af: University Health Network, Toronto

[68GA] GA-Pentixafor (CXCR4) PET/MR til indledende iscenesættelse og opfølgning i multiple myelomer: Prospektiv sammenligning med standard for pleje PET/CT og evaluering af terapiindflydelse

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigators will be focusing on Multiple Myeloma patients, a disease mainly located in the participants bones. The goal of this clinical trial is to evaluate the diagnostic and prognostic value of CXCR4-targeted PET/MR imaging in patients with Multiple Myeloma (MM), comparing it to the standard 18F-FDG-PET/CT and MRI imaging for the initial staging, follow-up, and treatment decision-making. The study will focus on newly diagnosed MM patients and those who may undergo stem cell transplantation.

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 imaging offers improved accuracy, better tumor detection, and a greater influence on treatment decisions.

This study aims to establish whether combining CXCR4-targeted PET/MR imaging could become a comprehensive diagnostic tool for MM, enhancing disease monitoring, guiding therapeutic decisions, and reducing patient burden by eliminating the need for multiple imaging sessions.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Rekruttering
        • University Health Network

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: [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.

Andre navne:
  • CXCR4

Hvad måler undersøgelsen?

Primære resultatmål

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

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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire
Tidsramme: Post-initial staging (before starting treatment)

Using a questionnaire, the investigators aim to evaluate how hematologists make treatment decisions based on the addition of CXCR4 PET/MR imaging influences in MM patients, including adjustments in preconditioning, evaluation for radiotherapy, decisions for or against stem cell transplantation, and changes in follow-up schedules.
Post-initial staging (before starting treatment)
Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire
Tidsramme: 3 months after start of participants therapy for MM

Using a questionnaire, the investigators aim to evaluate how hematologist assess how the availability of CXCR4 PET/MR affects decisions during therapy response assessment. This could include changes in imaging follow-up, supportive therapy decisions, or additional evaluations.
3 months after start of participants therapy for MM
Gather data to inform on patient selection for theranostics studies
Tidsramme: Baseline (initial staging)

The investigators will collect all data measurements on imaging and disease characteristics from CXCR4 imaging and standard-of-care imaging, integrating these findings to form a comprehensive assessment of whether patients may be suitable candidates for theranostic studies
Baseline (initial staging)
Monitoring for Adverse Events Related to Radiopharmaceutical Administration
Tidsramme: 6 months (from baseline to final follow-up)

Document any adverse events following the administration of the radiopharmaceutical [68Ga]Ga-PentixaFor during PET/MR imaging, including any potential side effects or safety concerns.
6 months (from baseline to final follow-up)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Health Network, Toronto

Efterforskere

  • Ledende efterforsker: Patrick Veit-Haibach, MD, University Health Network, Toronto

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. april 2025

Primær færdiggørelse (Anslået)

4. marts 2028

Studieafslutning (Anslået)

4. marts 2028

Datoer for studieregistrering

Først indsendt

27. februar 2025

Først indsendt, der opfyldte QC-kriterier

6. marts 2025

Først opslået (Faktiske)

11. marts 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 23-5828

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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