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68Ga-pentixather and 68Ga-pentixafor PET/CT in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05364177
Recruitment Status : Recruiting
First Posted : May 6, 2022
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
Chemokine receptor-4 (CXCR4) is overexpressed in multiple myeloma (MM) cells. 68Ga-pentixafor is a radio-labled tracer for CXCR4 . 68Ga-pentixafor PET/CT has shown good diagnostic performance in MM. But an exchange of Ga3+ by Lu3+ or Y3+ will lead to a significant loss of CXCR4 affinity. Investigators conduct this prospective study to evaluate the diagnostic performance of 68Ga-pentixather compared with 68Ga-pentixafor, in order to parallel 68Ga-pentixather and 177Lu/90Y-pentixather in theranostics of MM.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: 68Ga-Pentixather Drug: 68Ga-Pentixafor Early Phase 1

Detailed Description:
Multiple myeloma (MM) is a malignant plasma cell disorder which is characterized by clonal proliferation of plasma cell in bone marrow microenvironment. Chemokine receptor-4 (CXCR4) is overexpressed in MM cells, and has been identified as a potential therapy target. 68Ga-pentixafor is a radiolabeled ligand with high affinity for CXCR4. 68Ga-pentixafor PET/CT has been reported with better diagnostic performance than 18F-FDG PET/CT. However, considering both diagnostic and therapeutic applications, an exchange of Ga3+ by other M3+ ions (Lu or Y) will lead to a significant loss of CXCR4 affinity. Thus, pentixather was developed as the precursor of 177Lu-pentixather or 90Y-pentixather, which can be used in CXCR4-targeted peptide receptor radionuclide therapy (PRRT). Investigators conduct this prospective study to evaluate the diagnostic performance of 68Ga-pentixather compared with 68Ga-pentixafor, in order to parallel 68Ga-pentixather and 177Lu/90Y-pentixather in theranostics of MM.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 68Ga-pentixather PET/CT, 68Ga-pentixafor PET/CT
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of 68Ga-pentixather and 68Ga-pentixafor PET/CT in Patients With Multiple Myeloma
Actual Study Start Date : August 11, 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
Experimental: 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan
Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval
Drug: 68Ga-Pentixather
After intravenous injection of 68Ga-pentixather, PET/CT scan will be performed.
Other Name: 68Ga-Pentixather injection

Drug: 68Ga-Pentixafor
After intravenous injection of 68Ga-pentixafor, PET/CT scan will be performed.
Other Name: 68Ga-Pentixafor injection




Primary Outcome Measures :
  1. Metabolic parameter [ Time Frame: through study completion, an average of 2 years ]
    Comparison of metabolic parameter (SUVmax) between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.

  2. PET-positive diffuse bone marrow involvement [ Time Frame: through study completion, an average of 2 years ]
    Comparison of the number of diffuse bone marrow involvement between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.

  3. PET-positive focal bone marrow lesions [ Time Frame: through study completion, an average of 2 years ]
    Comparison of the number of focal bone marrow lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.

  4. PET-positive extramedullary lesions [ Time Frame: through study completion, an average of 2 years ]
    Comparison of the number of extramedullary lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.


Secondary Outcome Measures :
  1. Adverse effects [ Time Frame: through study completion, an average of 2 years ]
    Types of adverse events.

  2. Tumor burden assessment [ Time Frame: through study completion, an average of 2 years ]
    The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and clinical staging

  3. Follow-up assessment [ Time Frame: through study completion, an average of 2 years ]
    The correlation between metabolic parameter (SUVmax) in 68Ga-pentixather PET/CT and follow-up parameter (PFS).

  4. CXCR4 expression in biopsies and metabolic parameters in PET [ Time Frame: through study completion, an average of 2 years ]
    The correlation between CXCR4 expression in biopsies and metabolic parameter (SUVmax) in PET.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Suspected or confirmed untreated multiple myeloma (MM), relapsed MM, MM in remission
  2. Signed written consent

Exclusion Criteria:

  1. pregnancy
  2. breastfeeding
  3. known allergy against pentixather or pentixafor
  4. any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05364177


Contacts
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Contact: Li Huo, MD. 86-10-69155537 huoli@pumch.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100005
Contact: Li Huo, MD.    86-10-69155537    huoli@pumch.cn   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Qiao Yang, MD. Peking Union Medical College Hospital
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT05364177    
Other Study ID Numbers: PUMCH-MM-pentixather
First Posted: May 6, 2022    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
multiple myeloma
CXCR4
68Ga-pentixather
PET/CT
68Ga-pentixafor
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases