NCT05364177

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for early_phase_1 multiple-myeloma

Timeline
Completed

Started Aug 2021

Typical duration for early_phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 6, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

November 10, 2021

Last Update Submit

May 3, 2022

Conditions

Multiple Myeloma

Keywords

multiple myelomaCXCR468Ga-pentixatherPET/CT68Ga-pentixafor

Outcome Measures

Primary Outcomes (4)

  • Metabolic parameter

    Comparison of metabolic parameter (SUVmax) between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.

    through study completion, an average of 2 years

  • PET-positive diffuse bone marrow involvement

    Comparison of the number of diffuse bone marrow involvement between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.

    through study completion, an average of 2 years

  • PET-positive focal bone marrow lesions

    Comparison of the number of focal bone marrow lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.

    through study completion, an average of 2 years

  • PET-positive extramedullary lesions

    Comparison of the number of extramedullary lesions between 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT.

    through study completion, an average of 2 years

Secondary Outcomes (4)

  • Adverse effects

    through study completion, an average of 2 years

  • Tumor burden assessment

    through study completion, an average of 2 years

  • Follow-up assessment

    through study completion, an average of 2 years

  • CXCR4 expression in biopsies and metabolic parameters in PET

    through study completion, an average of 2 years

Study Arms (1)

68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan

EXPERIMENTAL

Participants with multiple myeloma will perform 68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT within 7-day interval

Drug: 68Ga-PentixatherDrug: 68Ga-Pentixafor

Interventions

68Ga-PentixatherDRUG

After intravenous injection of 68Ga-pentixather, PET/CT scan will be performed.

Also known as: 68Ga-Pentixather injection
68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan
68Ga-PentixaforDRUG

After intravenous injection of 68Ga-pentixafor, PET/CT scan will be performed.

Also known as: 68Ga-Pentixafor injection
68Ga-pentixather PET/CT and 68Ga-pentixafor PET/CT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100005, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

68Ga-pentixafor

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Qiao Yang, MD.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Huo, MD.

CONTACT

86-10-69155537huoli@pumch.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: 68Ga-pentixather PET/CT, 68Ga-pentixafor PET/CT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2021

First Posted

May 6, 2022

Study Start

August 11, 2021

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

May 6, 2022

Record last verified: 2022-05

Locations

CN(1)