NCT06412952

Brief Summary

The aim of this study was to investigate the value of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high WHO grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (PET/CT).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 1, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1.7 years

First QC Date

April 26, 2024

Last Update Submit

May 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • SUVmax

    SUVmax of focal lesions are measured on 68Ga-RM26 PET/CT.

    through study completion, an average of 1.5 years

Study Arms (1)

68Ga-RM26, PET/CT

EXPERIMENTAL

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

Drug: 68Ga-RM26

Interventions

Intravenous injection of one dosage of 74-185 MBq(2-5 mCi) 68Ga-RM26. Tracer doses of 68Ga- RM26 will be used to image lesions of glioma by PET/CT.

Also known as: 68Ga-GRPR antagonist
68Ga-RM26, PET/CT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • suspected or confirmed untreated glioma patients
  • 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)

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (2)

  • Li Y, Wang R, Chen J, Zhu Z, Wang Y, Ma W. 68Ga-NOTA-RM26 PET/CT in the evaluation of glioma: a pilot prospective study. EJNMMI Res. 2025 Jan 17;15(1):6. doi: 10.1186/s13550-025-01198-7.

  • Wang R, Li Y, Li Z, Wang J, Li L, Xiang J, Jia C, Peng X, Wang Y, Ma W, Wang L, Jia W, Chen X, Li D, Zhu Z, Zhang J. Gastrin-Releasing Peptide Receptor Targeting PET/CT With 68 Ga-NOTA-RM26 in the Assessment of Glioma and Combined Multiregional Biopsies. Clin Nucl Med. 2025 Apr 1;50(4):316-323. doi: 10.1097/RLU.0000000000005651. Epub 2025 Jan 14.

MeSH Terms

Conditions

Glioma

Interventions

68Ga-NOTA-RM26

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Zhaohui Zhu

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

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

April 26, 2024

First Posted

May 14, 2024

Study Start

October 1, 2022

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations