Clinical trial · Interventional
First Human Trial of Targeting MDM2/MDMX PET Imaging
First in Human Study on PET Imaging of Solid Tumors Using an MDM2/MDMX-Specific Probe
NCT06443762CI-TRIAL-00090441completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MDM2/MDMX Gene Mutation | — | UNRESOLVED | — |
| Nuclear Medicine | — | UNRESOLVED | — |
| Positron Emission Tomography Imaing | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga] MDM2/MDMX Peptide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group patients who underwent PET scanning with injection probes
- description
- \[68Ga\] 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.
- interventionNames
- Drug: [68Ga] MDM2/MDMX Peptide
Primary outcomes (1)
- measure
- SUV
- timeFrame
- 1 hour and 2 hours after drug injection
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.