Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NOTA-RM26 PET/CT | Experimental | The patients were injected with 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 in one dose intravenously and underwent PET/CT scan 30-45 min later |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Standardized uptake value of 68Ga-NOTA-RM26 in breast tumor | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events collection | Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Zang, MD | Contact | +86 10 69154196 | 15901495106@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhaohui Zhu, MD,PHD | Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628612 | 68Ga-NOTA-RM26 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |