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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06412952
Enrollment
30
Registered
2024-05-14
Start date
2022-10-01
Completion date
2024-05-31
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioma

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).

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.

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.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SUVmaxthrough study completion, an average of 1.5 yearsSUVmax of focal lesions are measured on 68Ga-RM26 PET/CT.

Countries

China

Contacts

Primary ContactZhaohui Zhu
13611093752@163.com+8613611093752
Backup ContactRongxi Wang
pumch_jacobwong@163.com+8615584172170

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026