NCT03436342

Brief Summary

Chemokine receptor CXCR4 was expressed in MM and lymphoma cells and CXCR4-targeting molecular imaging- 68Ga-Pentixafor PET/CT could be a promising technique to evaluate the extent of MM and lymphoma with higher accuracy. This prospective study is going to investigate whether metabolic characterization by 68Ga-Pentixafor PET/CT may be superior for diagnosis, risk stratification, and prognostic evaluation of MM and lymphoma.

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 Jun 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

October 25, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 27, 2019

Status Verified

June 1, 2019

Enrollment Period

9 months

First QC Date

October 25, 2017

Last Update Submit

December 26, 2019

Conditions

Multiple MyelomaLymphoma

Outcome Measures

Primary Outcomes (1)

  • SUVmax

    SUVmax of focal lesions are measured on 68Ga-Pentixafor PET/CT. The SUVmax of the L3 vertebra is defined as the general marrow activity on the condition that there is no focally hypermetabolic disease.

    through study completion, an average of 2 years

Secondary Outcomes (8)

  • Diagnostic value

    through study completion, an average of 2 years

  • Incidence of emergency events during the study

    through study completion, an average of 2 years

  • Tumor burden assessement

    through study completion, an average of 2 years

  • Diagnostic value in special type of multiple myeloma

    through study completion, an average of 2 years

  • CXCR4 expression and SUV

    through study completion, an average of 2 years

  • +3 more secondary outcomes

Study Arms (1)

68Ga-Pentixafor, PET/CT

EXPERIMENTAL

Inject 68Ga-Pentixafor and then perform PET/CT scan.

Drug: 68Ga-Pentixafor

Interventions

68Ga-PentixaforDRUG

Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga-Pentixafor will be used to image lesions of MM and lymphoma by PET/CT.

68Ga-Pentixafor, PET/CT

Eligibility Criteria

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

You may qualify if:

  • suspected or confirmed untreated MM or lymphoma patients
  • F-FDG PET/CT within two weeks
  • signed written consent.

You may not qualify if:

  • pregnancy
  • breastfeeding
  • known allergy against 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)

Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science

Beijing, 100730, China

RECRUITING

Related Publications (2)

  • Pan Q, Chen Z, Liu S, Zhang H, Feng J, Miao W, Li F, Cao X, Luo Y. Reduced splenic uptake of [68Ga]Ga-Pentixafor following first-line chemotherapy is associated with poor prognosis in patients with newly diagnosed multiple myeloma. EJNMMI Res. 2025 Jun 20;15(1):74. doi: 10.1186/s13550-025-01262-2.

    PMID: 40540129DERIVED

  • Pan Q, Cao X, Luo Y, Li J, Feng J, Li F. Chemokine receptor-4 targeted PET/CT with 68Ga-Pentixafor in assessment of newly diagnosed multiple myeloma: comparison to 18F-FDG PET/CT. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):537-546. doi: 10.1007/s00259-019-04605-z. Epub 2019 Nov 27.

    PMID: 31776631DERIVED

MeSH Terms

Conditions

Multiple MyelomaLymphoma

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 DiseasesLymphatic Diseases

Study Officials

  • Fang Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Li, M.D.

CONTACT

86-10-69155502lifang@pumch.cn

Yaping Luo, M.D.

CONTACT

86-10-69157033luoyaping@live.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

February 19, 2018

Study Start

June 1, 2019

Primary Completion

March 1, 2020

Study Completion

December 1, 2020

Last Updated

December 27, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)