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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Tumor

Intervention / Treatment
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* Drug: 68Ga-NOTA-RM26


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NOTA-RM26 PET/CT<br>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 | Drug: 68Ga-NOTA-RM26<br>* 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |