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Trial Title:
68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients
NCT ID:
NCT05549024
Condition:
Breast Cancer
Prostate Cancer
Brain Tumor
PET/CT Imaging
Conditions: Official terms:
Brain Neoplasms
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
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.
Arm group label:
68Ga-RM26-RGD and 18F-FDG PET/ CT scan
Arm group label:
68Ga-RM26-RGD and 68Ga-RGD PET/ CT scan
Arm group label:
68Ga-RM26-RGD and 68Ga-RM26 PET/ CT scan
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
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.
Criteria for 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
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, MD,PHD
Phone:
86+13611093752
Email:
13611093752@163.com
Start date:
August 16, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05549024
