MDM2/MDMX Gene Mutation, Nuclear Medicine, Positron Emission Tomography Imaing
Conditions
Brief summary
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.
Interventions
DRUG[68Ga] MDM2/MDMX Peptide
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.
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ages 18 to 75 years, both males and females are eligible; 2. Participants must meet the following criteria for blood routine and liver/kidney function tests: Complete blood count: WBC ≥ 4.0 × 10\^9/L or neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); liver and kidney function: Total bilirubin ≤ 1.5 times the upper threshold limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for participants with liver metastasis, alkaline phosphatase (ALP) ≤ 2.5 ULN (if bone or liver metastases are present, ALP ≤ 4.5 ULN); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT; 3. Normal cardiac function; 4. An expected survival of ≥ 12 weeks; 5. Good follow-up compliance; 6. According to RECIST 1.1 criteria, there must be at least one measurable target lesion; 7. Women of childbearing age (15-49 years) must have a negative pregnancy test conducted within 7 days prior to enrollment; patients of childbearing potential must agree to use effective contraceptive methods to ensure they do not conceive during the study and for three months after examinations; 8. Patients recommended for PET/CT evaluation for tumor diagnosis and staging by a clinician; 9. Participants must fully understand the study and voluntarily participate, and must sign an informed consent form.
Exclusion criteria
1. Severe abnormalities in liver and kidney function as well as hematological parameters; 2. Patients who are planning a pregnancy; 3. Pregnant or lactating women; 4. Individuals unable to lie flat for thirty minutes; 5. Individuals who refuse to participate in this clinical study; 6. Individuals suffering from claustrophobia or other psychiatric disorders; 7. Other conditions deemed by the researchers as unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUV | 1 hour and 2 hours after drug injection | 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. |
Countries
China
Outcome results
None listed