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

May 8, 2024 updated by: Peking Union Medical College Hospital
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Chinese Academy of Medical Science & Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-RM26, PET/CT
Inject 68Ga-Pentixafor and then perform PET/CT scan.
Drug: 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.
Other Names:
  • 68Ga-GRPR antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVmax
Time Frame: through study completion, an average of 1.5 years
SUVmax of focal lesions are measured on 68Ga-RM26 PET/CT.
through study completion, an average of 1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Zhaohui Zhu, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

April 26, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUMCH-68Ga-RM26 in Glioma

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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