Clinical trial NCT05549024: 68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients
Official title: 68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Prostate Cancer
Brain Tumor
PET/CT Imaging
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Diagnostic performance1
timeFrame: through study completion, an average of 1 year
measure: Diagnostic performance2
timeFrame: through study completion, an average of 1 year
measure: Diagnostic performance3
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The dosimetry of 68Ga-RM26-RGD
timeFrame: through study completion, an average of 1 year
measure: 68Ga-RM26-RGD uptake at different tumors
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Zhaohui Zhu, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: