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

Early Phase 1

Recruiting

• Conditions: Prostate Cancer; PET/CT Imaging; Breast Cancer; Brain Tumor
• Interventions: Drug: 68Ga-RM26-RGD; Drug: 68Ga-RM26; Drug: 68Ga-RGD; Drug: 18F-FDG

• Registration Number: NCT05549024
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2022-08-16
• Study First Submitted: 2022-09-18
• Study First Submitted QC: 2022-09-18
• Study First Posted: 2022-09-22
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China