68Ga-NOTA-RM26 PET/CT in Glioma Patients

NCT ID: NCT06412952

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label brain PET/ CT study was designed to assess its clinical diagnostic value in patients with glioma.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

68Ga-RM26, PET/CT

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

Group Type EXPERIMENTAL

68Ga-RM26

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68Ga-RM26

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

68Ga-GRPR antagonist

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* suspected or confirmed untreated glioma patients
* signed written consent.

Exclusion Criteria

* pregnancy
* breastfeeding
* known allergy against Pentixafor
* any medical condition that in the opinion of the investigator,may
* significantly interfere with study compliance
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhaohui Zhu

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zhaohui Zhu

Role: CONTACT

+8613611093752

Rongxi Wang

Role: CONTACT

+8615584172170

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Zhaohui Zhu, MD

Role: primary

+8619800370331

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39821814 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39806560 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PUMCH-68Ga-RM26 in Glioma

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Direct Comparison of Ga-68-DOTATATE and Ga-68-DOTATOC
NCT04298541 NOT_YET_RECRUITING PHASE2