Multiple MyelomaNCT06871176
PET/MR Scan With [68Ga]Ga-PentixaFor (CXCR4) vs Standard of Care (SOC) for Initial Staging and Follow up in Multiple Myeloma (MM)
A study testing [68Ga]Ga-PentixaFor in people with Multiple Myeloma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- [68Ga]Ga-PentixaFor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2025to 4 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vishal Kukreti, MD contact
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2N2
About this study
Official title: [68Ga]Ga-PentixaFor (CXCR4) PET/MR for Initial Staging and Follow up in Multiple Myeloma: Prospective Comparison With Standard of Care PET/CT and Evaluation of Therapy Influence
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.
Read the detailed description
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.
- Conditions
- Multiple Myeloma
- Being tested
- [68Ga]Ga-PentixaFor
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PentixaForDrug
Also called CXCR4
[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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [68Ga]Ga-PentixaFor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (at initial staging)
Secondary outcomes (4)
Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire
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.
Measured: Post-initial staging (before starting treatment)
Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire
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.
Measured: 3 months after start of participants therapy for MM
Gather data to inform on patient selection for theranostics studies
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
Measured: Baseline (initial staging)
Monitoring for Adverse Events Related to Radiopharmaceutical Administration
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.
Measured: 6 months (from baseline to final follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start22 Apr 2025
- Primary completion4 Mar 2028 (estimated)
- Study completion4 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Veit-Haibach, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871176
- Sponsor's protocol ID
- 23-5828
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga-PentixaFor (CXCR4) PET/MR for Initial Staging and Follow up in Multiple Myeloma: Prospective Comparison With Standard of Care PET/CT and Evaluation of Therapy Influence
- ClinicalTrials.gov ID
- NCT06871176
- Acronym / sponsor ID
- 23-5828
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 4 Mar 2028 (estimated)
- Study completion
- 4 Mar 2028 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging | Experimental | Drug: [68Ga]Ga-PentixaForThis 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-PentixaForAlso: CXCR4[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. | Drug | CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging |
Primary outcome
Diagnostic Accuracy of CXCR4-targeted [68Ga]Ga-PentixaFor PET/MR Imaging Compared to Standard of Care Imaging
Time frame: 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.
4 secondary outcomes
Evaluating the Role of CXCR4-targeted Imaging in Treatment Decision Making Using a Questionnaire
Time frame: Post-initial staging (before starting treatment)
Evaluating the Role of CXCR4-targeted Imaging in Response Assessment Using a Questionnaire
Time frame: 3 months after start of participants therapy for MM
Gather data to inform on patient selection for theranostics studies
Time frame: Baseline (initial staging)
Monitoring for Adverse Events Related to Radiopharmaceutical Administration
Time frame: 6 months (from baseline to final follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vishal Kukreti, MD contact
Patrick Veit-Haibach, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-PentixaFor in people with Multiple Myeloma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Veit-Haibach, MD (416-340-4800 Ext. 6085, Patrick.Veit-Haibach@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.