NCT03347864

68Ga-NOTA-RM26 PET/CT in Breast Tumor Patients

Diagnostic Performance of 68Gallium-labeled NOTA-RM26 PET/CT in Breast Tumor Patients

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label positron emission tomography/computed tomography(PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in breast tumor patients. 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26A will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

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 whole-body PET/ CT study was designed to assess its clinical diagnostic value in patients with breast tumor.

Conditions

• Breast Tumor

Interventions

Type	Name	Description
DRUG	68Ga-NOTA-RM26	1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans

Timeline

• Start date: 2016-10-01
• Primary completion: 2018-10-01
• Completion: 2018-10-01
• First posted: 2017-11-20
• Last updated: 2017-11-20

Locations

1 site across 1 country: China