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Investigation of the Radiotracer Uptake of [68Ga] MDM2/MDMX Peptide at Lesion Sites in Patients with Malignant Tumors, and Evaluation of the Capability of [68Ga] MDM2/MDMX Peptide to Detect Overexpression of MDM2/MDMX in Tumor Patients, Particularly Those with Recurrent or Advanced Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group patients who underwent PET scanning with injection probes | Experimental | [68Ga] MDM2/MDMX Peptide PET/CT Imaging: Patients are intravenously injected with prepared and quality-assured [68Ga] MDM2/MDMX Peptide (0.05-0.1 mCi/kg). Imaging is performed 40 minutes to 1 hour post-injection using either the United Imaging uEXPLORER 2m PET/CT or Siemens Biograph m-CT flow PET/CT for whole-body scans, extending from the top of the head to the feet. In cases where conventional imaging reveals indeterminate lesions, delayed imaging is conducted for further differentiation. The patient is positioned supine with calm respiration. The imaging conditions for the head and torso remain as described above. Data are reconstructed using the OSEM method to produce coronal, sagittal, and axial PET and PET/CT fusion images. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [68Ga] MDM2/MDMX Peptide | Drug | Utilizing a peptide with high affinity to MDM2/MDMX as the targeting moiety for radiopharmaceuticals, this study explores the diagnostic efficacy of [68Ga] MDM2/MDMX Peptide in patients with malignant tumors exhibiting high MDM2/MDMX expression. This approach not only provides a basis for the early diagnosis of malignant tumors but also facilitates the formulation of effective precision therapy strategies tailored to the tumor's MDM2/MDMX expression profile, particularly for patients with recurrent and metastatic disease. [68Ga] MDM2/MDMX Peptide, a novel MDM2/MDMX-targeted molecular probe labeled with 68Ga, utilizes DOTA as a bifunctional chelator for complexing with 68Ga3+. The labeling process is straightforward, allowing for direct use without purification, and demonstrates high in vivo stability. |
| Measure | Description | Time Frame |
|---|---|---|
| SUV | Standardized Uptake Values (SUV) of [68Ga] MDM2/MDMX Peptide at various time points within the imaging window for target lesions or suspected tumor lesions in subjects with solid tumors or suspected solid tumors. | 1 hour and 2 hours after drug injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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