68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients

Study Overview
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Brief Summary
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Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. In this study, a novel dual-target imaging agent 68Ga-RM26-RGD was used for clinical study of tumor PET/CT imaging to further verify its clinical application value.

Detailed Description
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Conventional 18F-FDG PET/CT has important diagnostic value in cell metabolism level, early metastasis, judging malignant potential and prognosis of tumors. It has been routinely used for staging and restaging of most tumors, but there are still some tumors with low uptake of 18F-FDG PET/CT. Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on GRPr expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors such as breast\brain\prostate tumor which have high GRPr and αvβ3 receptor expression . In this study, a novel dual-target imaging agent 68Ga-RM26-RGD was used for PET/CT imaging of breast\brain\prostate cancer, compared with conventional 18F-FDG, or single target imaging agent 68Ga-RGD or 68Ga-RM26 PET/CT imaging.

Official Title
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68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients

Conditions
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Breast Cancer, Prostate Cancer, Brain Tumor, PET/CT Imaging

Intervention / Treatment
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* Drug: 68Ga-RM26-RGD
* Drug: 18F-FDG
* Drug: 68Ga-RM26
* Drug: 68Ga-RGD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with confirmed or suspected breast/brain/prostate cancer; 68Ga-RM26-RGD and 18F-FDG(or 68Ga-RM26 or 68Ga-RGD) PET/CT within 2 week; signed written consent. Exclusion Criteria: pregnancy; breastfeeding; any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-RM26-RGD and 18F-FDG PET/ CT scan<br>Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 18F-FDG, respectively. | Drug: 68Ga-RM26-RGD<br>* Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.<br>* Other names: 68Ga-RM26-RGD injection;Drug: 18F-FDG<br>* 18F-FDG injection<br>* Other names: Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55 MBq (0.1-0.15 mCi)/kg.;|
| Experimental: 68Ga-RM26-RGD and 68Ga-RM26 PET/ CT scan<br>Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RM26, respectively. | Drug: 68Ga-RM26-RGD<br>* Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.<br>* Other names: 68Ga-RM26-RGD injection;Drug: 68Ga-RM26<br>* Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.<br>* Other names: 68Ga-RM26 injection;|
| Experimental: 68Ga-RM26-RGD and 68Ga-RGD PET/ CT scan<br>Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RGD, respectively. | Drug: 68Ga-RM26-RGD<br>* Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.<br>* Other names: 68Ga-RM26-RGD injection;Drug: 68Ga-RGD<br>* Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.<br>* Other names: 68Ga-RGD injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance1 | comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 18F-FDG PET/CT | through study completion, an average of 1 year | 
| Diagnostic performance2 | comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RM26 PET/CT | through study completion, an average of 1 year | 
| Diagnostic performance3 | comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RGD PET/CT | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dosimetry of 68Ga-RM26-RGD | Measure the distribution of 68Ga-RM26-RGD in GRPR and αvβ3 positive tumor patients by 2-hour dynamic PET/CT acquisition by dosimetry software | through study completion, an average of 1 year | 
| 68Ga-RM26-RGD uptake at different tumors | The SUV uptake of tumors and metastases in patients with breast/brain/prostate cancer was measured. | through study completion, an average of 1 year |