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

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.

• 68Ga-NOTA-RM26 (Drug): 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans

Primary outcomes

• Standardized uptake value of 68Ga-NOTA-RM26 in breast tumor [1 year]: The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured.

Secondary outcomes

• Adverse events collection [1 week]: Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed

Sex: Female, ages: 18 Years to 80 Years

Inclusion Criteria:

* patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form

Exclusion Criteria:

* The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with GRPR binding

• Zhaohui Zhu, MD,PHD, Study chair, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College