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

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

Sponsors

Lead Sponsor: Peking Union Medical College Hospital

Source Peking Union Medical College Hospital
Brief Summary

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

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.

Overall Status Recruiting
Start Date 2022-08-16
Completion Date 2023-12-31
Primary Completion Date 2023-12-31
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Diagnostic performance1 through study completion, an average of 1 year
Diagnostic performance2 through study completion, an average of 1 year
Diagnostic performance3 through study completion, an average of 1 year
Secondary Outcome
Measure Time Frame
The dosimetry of 68Ga-RM26-RGD through study completion, an average of 1 year
68Ga-RM26-RGD uptake at different tumors through study completion, an average of 1 year
Enrollment 90
Condition
Intervention

Intervention Type: Drug

Intervention Name: 68Ga-RM26-RGD

Description: Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.

Other Name: 68Ga-RM26-RGD injection

Intervention Type: Drug

Intervention Name: 18F-FDG

Description: 18F-FDG injection

Arm Group Label: 68Ga-RM26-RGD and 18F-FDG PET/ CT scan

Other Name: Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55 MBq (0.1-0.15 mCi)/kg.

Intervention Type: Drug

Intervention Name: 68Ga-RM26

Description: Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.

Arm Group Label: 68Ga-RM26-RGD and 68Ga-RM26 PET/ CT scan

Other Name: 68Ga-RM26 injection

Intervention Type: Drug

Intervention Name: 68Ga-RGD

Description: Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.

Arm Group Label: 68Ga-RM26-RGD and 68Ga-RGD PET/ CT scan

Other Name: 68Ga-RGD injection

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Zhaohui Zhu, MD,PHD Principal Investigator Peking Union Medical College Hospital
Overall Contact

Last Name: Zhaohui Zhu, MD,PHD

Phone: 86+13611093752

Email: [email protected]

Location
Facility: Status: Contact: Peking Union Medical College Hospital Zhaohui Zhu, MD,PHD 86+13611093752 [email protected]
Location Countries

China

Verification Date

2022-09-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: 68Ga-RM26-RGD and 18F-FDG PET/ CT scan

Type: Experimental

Description: Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 18F-FDG, respectively.

Label: 68Ga-RM26-RGD and 68Ga-RM26 PET/ CT scan

Type: Experimental

Description: Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RM26, respectively.

Label: 68Ga-RM26-RGD and 68Ga-RGD PET/ CT scan

Type: Experimental

Description: Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RGD, respectively.

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

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