First in Human Study on PET Imaging of Solid Tumors Using an MDM2/MDMX-Specific Probe
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- SUV
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages 18 to 75 years, both males and females are eligible;
- •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;
- •Normal cardiac function;
- •An expected survival of ≥ 12 weeks;
- •Good follow-up compliance;
- •According to RECIST 1.1 criteria, there must be at least one measurable target lesion;
- •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;
- •Patients recommended for PET/CT evaluation for tumor diagnosis and staging by a clinician;
- •Participants must fully understand the study and voluntarily participate, and must sign an informed consent form.
Exclusion Criteria
- •Severe abnormalities in liver and kidney function as well as hematological parameters;
- •Patients who are planning a pregnancy;
- •Pregnant or lactating women;
- •Individuals unable to lie flat for thirty minutes;
- •Individuals who refuse to participate in this clinical study;
- •Individuals suffering from claustrophobia or other psychiatric disorders;
- •Other conditions deemed by the researchers as unsuitable for participation in the trial.
Arms & Interventions
Experimental group patients who underwent PET scanning with injection probes
[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.
Intervention: [68Ga] MDM2/MDMX Peptide (Drug)
Outcomes
Primary Outcomes
SUV
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported